TR-Surgical and Non Surgical Method For Vaginal Tightening

2017
SURGICAL AND NON-SURGICAL (INSTRUMENTAL)

METHOD FOR VAGINAL TIGHTENING
HEALTH TECHNOLOGY ASSESSMENT SECTION (MaHTAS)

MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
HEALTH TECHNOLOGY ASSESSMENT SECTION
012/2017
MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH
i
MALAYSIA
012/2017
DISCLAIMER
Technology review is a brief report, prepared on an urgent basis, which draws
on restricted reviews from analysis of pertinent literature, on expert opinion
and / or regulatory status where appropriate. It has not been subjected to an
external review process. While effort has been made to do so, this document
may not fully reflect all scientific research available. Additionally, other
relevant scientific findings may have been reported since completion of this
review.
Please contact: htamalaysia@moh.gov.my, if you would like further

information.
Health Technology Assessment Section (MaHTAS),

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya
Tel: 603 88831246
Fax: 603 8883 1230
Available at the following website: http://www.moh.gov.my
i
Prepared by:
Balqis Abdul Ghani
Principal Assistant Director
Health Technology Assessment Section (MaHTAS)
Reviewed by:
Dr Junainah Binti Sabirin
Public Health Physician
Deputy Director
Health Technology Assessment Section (MaHTAS)
External reviewers:
Ms (Dr) Salina Ibrahim
Senior Consultant Plastic Surgeon
Head of Clinical Services (Plastic Surgery)
Dr Shah Jumaat Mohd. Yussof

Head of Plastic Surgery
Faculty of Medicine
University Teknologi MARA
Sungai Buloh, Selangor
Dr Ravichandran A/L R. Jeganathan

Senior Consultant Obstetrics & Gynaecology
Head of Clinical Services (Obstetrics & Gynaecology)
Dr Aruku Naidu
Consultant Urogynaecologist
Hospital Raja Permaisuri Bainun
Ipoh, Perak
DISCLOSURE
The author of this report has no competing interest in this subject and the
preparation of this report is totally funded by the Ministry of Health, Malaysia.
ii
EXECUTIVE SUMMARY
Background
Pregnancies, childbirth, aging, genetics, pelvic trauma and strenuous activity in

women may contributes to pelvic floor weakness, resulting in stress urinary
incontinence (SUI), vaginal atrophy, decrease sensation during sexual
intercourse and generalised dissatisfaction with the appearance of the area.
Vaginal laxity is a symptom of pelvic floor dysfunction generally caused by

pregnancy and vaginal birth. Vaginal delivery may cause trauma to the pelvic
floor, which increased diameter of the genital hiatus. This may result in loss of
physical sensation and diminished sexual satisfaction (sexual gratification) during
intercourse. In an international survey among the members of the International
Urogynecological Association, it was reported that 83% of the 563 respondents
described vaginal laxity as under-reported by their patients, and the majority
considered it a self-reported bothersome condition which affects their sexual
function and relationship.
Female Genital Cosmetic Surgery (FGCS) refers to a non-medically indicated

cosmetic procedure which could change the structure and appearance of
otherwise healthy external genitalia of women, or internally in the case of vaginal
tightening. Vaginal rejuvenation is marketing rather than a medical nomenclature,
is a term that refers to repair of the vaginal canal and the opening of the vagina
for sexual function. Rejuvenation procedures share many characteristics with
therapeutic operations, but they focus primarily on tightening the lower vagina
and perineum, regardless of whether pelvic floor defects are present or absent.
Recently, energy based system has been introduced as a new, non-surgical,
non-invasive procedure for vaginal rejuvenation.
In a Global Aesthetic Survey 2016 conducted by International Society of

Aesthetic Plastic Surgery, labiaplasty procedure was noted to gain significant
demand with an increase of up to 45% request compared to the year 2015. In
Malaysia, the enquiries for laser vaginal rejuvenation have increased by 191% in
2016. However, there is no standardisation of rejuvenation procedures exist to
date in Malaysia. These procedures are increasingly advertised as being
beneficial by private clinics, despite the lack of robust evidence concerning their
benefits.
Hence, this technology review was requested by Medical Practise Division,

Ministry of Health Malaysia to review the safety and efficacy of surgical and non-
surgical (instrumental) method for vaginal tightening.
Objective/aim
To evaluate the safety, efficacy, cost-effectiveness and organizational issues of
surgical and non-surgical (instrumental) method for vaginal tightening.
iii
Results and conclusions
Effectiveness
a) Surgical method
There was limited fair level of retrievable evidence to show that surgical
vaginal tightening may increase sexual function to certain extend. These
effects can last up to 18 months with open surgery and for 24 months with
laser surgery. However most of the studies retrieved have small sample size,
no randomised with short-term follow up.
b) Non-surgical method
There was limited fair level of retrievable evidence to show that non-surgical
vaginal tightening may increase sexual function in women with vaginal laxity.
These effects are felt immediately and sustainable up to 12 months. However
most of the studies retrieved have small sample size, no randomised with
short-term follow up.
Safety
a) Surgical method
There was limited fair level of retrievable evidence to show that this method
was tolerable and safe. This method however was reported to have some
adverse side effects or complications such as dyspareunia (4.3-46.8%),
wound dehiscence (4%), bleeding/haematoma (2.1%), failed to achieve
desired results ( 2.1%) and decrease in vaginal lubrications. When laser was
used, patients do experience transient oedema and a tolerable heat
sensation.
adverse side effects or complications such as sporadic pain (23.3%) and
vaginal discharge (2.6%).
Psychological/Social/Ethical
a) Surgical method
There was limited fair level of retrievable evidence to suggest this method for
vaginal rejuvenation has variable satisfactory rate among the patient and the
partner/s. The satisfaction rates among women were range between 11.6%
to 87.9%. The partner/s reported a better satisfaction rate (92.6%).
There was limited fair level of retrievable evidence to suggest that this
method was tolerable and satisfactory to most women. The satisfaction rate
with these procedures was range between 76.5 to 93.0%. It was also noted
that the distress related to the sexual activity among these women was
iv
significantly reduced. However the assessment carried out was subjective
and short term effect.
Ethic
There was limited fair level of retrievable evidence to suggest that medical
doctors and medical students acknowledge the lack of evidence and scientific
support for vaginal tightening, but most did not raise ethical objections about
them.
Organizational
Three policy documents and one guideline were retrieved on the organizational
issues for vaginal tightening:
 Counselling should be a priority for women requesting for cosmetic
procedures.
 Women who wish to undergo these procedures should be given a thorough
explanation by the practitioner/obstetrician and gynaecologist.
 Practitioners/Obstetricians and gynaecologists should have a role in educating
women that there are a large number of variations in the appearance of
normal female external genitalia and that there are normal physiological
changes over time, especially following childbirth and menopause.
 Patients requesting procedures other than for gynaecological conditions
should be assessed thoroughly and the reasons for such a request assessed
carefully. Sexual counselling is also recommended for patients requesting
surgery that is purported to enhance gratification.
 Medical practitioners performing any vaginal surgery should be appropriately
trained to perform the procedures undertaken.
 Medical practitioners who perform these procedures should not promote or
advertise that these procedures to enhance sexual function per se.
Cost / Cost-effectiveness
There was no retrievable evidence on the cost effectiveness of surgical and non-
surgical method for vaginal tightening. In Malaysia, the fee of surgical procedures
for vaginal tightening range between RM12,000 and RM15,000, while the fee of
non-invasive laser procedures range between RM6,000 and RM10,000.
Methods
Electronic databases were searched through the Ovid interface: Ovid MEDLINE ®
In-process and other Non-indexed citations and Ovid MEDLINE® 1946 to
present, EMBASE – 1996 to August 2017, EBM Reviews - Cochrane Central
Register of Controlled Trials – August 2017, EBM Reviews - Cochrane Database
of Systematic Reviews - 2005 to August 2017, EBM Reviews - Health
Technology Assessment – 4th Quarter 2016, EBM Reviews – NHS Economic,
Evaluation Database 1st Quarter 2016. Searches were also run in PubMed.
Google was used to search for additional web-based materials and information.
Additional articles were identified from reviewing the references of retrieved
articles. Last search was conducted on 4 August 2017.
v
SURGICAL AND NON-SURGICAL (INSTRUMENTAL) METHOD FOR
VAGINAL TIGHTENING
1. BACKGROUND
The aesthetics procedures of the female genitalia have become an area of
particular concern among women over the past decade. Pregnancies,
childbirth, aging, genetics, pelvic trauma and strenuous activity in women may
contributes to pelvic floor weakness, resulting in stress urinary incontinence
(SUI), vaginal atrophy, decrease sensation during sexual intercourse and
generalised dissatisfaction with the appearance of the area.1
Vaginal laxity is a symptom of pelvic floor dysfunction generally caused by

pregnancy and vaginal birth. Vaginal delivery may cause trauma to the pelvic
floor, which increased diameter of the genital hiatus. This may result in loss of
physical sensation and diminished sexual satisfaction (sexual gratification)
during intercourse.2 In an international survey among the members of the
International Urogynecological Association, it was reported that 83% of the
563 respondents described vaginal laxity as under-reported by their patients,
and the majority considered it a self-reported bothersome condition which
affects their sexual function and relationship.3 Dietz et al reported the vaginal
laxity or „looseness‟ was common in their urogynecology service at a
prevalence of 24%.2
Female Genital Cosmetic Surgery (FGCS) refers to non-medically indicated

cosmetic procedures which could change the structure and appearance of
otherwise healthy external genitalia of women, and/or internally in the case of
vaginal tightening. This definition includes the most common procedure,
labiaplasty (LP), as well as others, such as hymenoplasty and vaginoplasty
(VP), also known as vaginal reconstruction and vaginal rejuvenation. 4 Vaginal
rejuvenation, a marketing rather medical nomenclature, is a term that refers to
repair of the vaginal canal and opening of the vagina for sexual function.5
These procedures are derived from classic gynaecologic treatments applied to
pelvic floor defects such as anterior vagina wall (cystocele), posterior vaginal
wall (rectocele) and vaginal apex (enterocele). The focus of the classic
procedures is to restore anatomic support and function by repairing damaged
tissues and reinforcing them where necessary. Rejuvenation procedures share
many characteristics with these therapeutic operations, but they focus
primarily on tightening the lower vagina and perineum, regardless of whether
pelvic floor defects are present or absent.6 Recently, energy-based system
has been introduced as a new, non-surgical, non-invasive procedure for
vaginal rejuvenation.1
Globally, there has been a great demand in vaginal rejuvenation. In a Global

Aesthetic Survey 2016 conducted by International Society of Aesthetic Plastic
Surgery, LP procedure was noted to gain significant demand with an increase
of up to 45% request compared to 2016.7 In Malaysia, the enquiries for laser
1
vaginal rejuvenation have increased by 191% in 2016.8 However, there is no
standardisation of tightening procedures exist to date in Malaysia. These
procedures are increasingly advertised as being beneficial by private clinics,
despite the lack of robust evidence concerning their benefits.4 A content
analysis of online advertisement for FGCS procedures from ten private
providers showed that the quality and quantity of clinical information in FGCS
provider sites were poor, with erroneous information in some instances.9
Hence, this technology review was requested by Medical Practise Division,

Ministry of Health Malaysia to review the safety and efficacy of surgical and
non-surgical (instrumental) method for vaginal tightening.
2. OBJECTIVE / AIM
To evaluate the safety, efficacy, cost-effectiveness and organizational issues
of surgical and non-surgical (instrumental) method for vaginal tightening.
3. TECHNICAL FEATURES
The most commonly performed procedures for vaginal tightening are
perineoplasty (PP) and VP.
Perineoplasty
Perineoplasty involves surgical reconstruction of the perineum, vulvar
vestibule, vaginal introitus and distal vagina. The scarred and redundant tissue
is excised, the opening attenuated and the superficial transverse perineal and
levator ani musculature reapproximated in the midline.10 This procedure is
undertaken to strengthen the pelvic floor, in which the perineal length is
restored following childbirth trauma or previous surgery.11
Vaginoplasty
Vaginoplasty involves surgery whereby portions of mucosa are excised from
the vaginal fornices via tools including scalpel, needle or radiofrequency (RF)
electrode, scissors, or laser. Currently, there was no standardization of the
procedures performed. This procedure may consist of an anterior
colporrhaphy, high posterior colporrhaphy, excision of lateral vaginal mucosa,
or a combination of the above. There were all designed to surgically “tighten”
the upper vagina for the purpose of increasing coital friction. 10
Energy-based devices
Energy-based devices applied thermal or non-thermal energy to the various
layers of the vaginal tissue, stimulating collagen regeneration contracture of
elastin fibers, neovascularisation, and improved vaginal lubrication.
Erbium:yttrium-aluminium-garnet (Er:YAG) lasers, carbon dioxide (CO2) lasers
and RF devices among the new energy-based devices used in vaginal
rejuvenation. Typically, the treatment session last ten to 20 minutes for laser
treatment and 15 to 30 minutes for RF treatment. None of these technologies
required anaesthesia and normal activities can be resumed the same day.1
2
The types of energy-based devices available for vaginal rejuvenation are
summarised in Table 1.
Table 1: Energy-based devices for vaginal rejuvenation
Energy-based device Type Description

Laser-based devices
FemiLift Alma Lasers Fractional CO2 laser  Induces collagen deposition via concentrated
thermal heating of the inner vaginal tissue
layer
Monalisa Touch Fractional CO2 laser  Stimulate and promote the regeneration of
collagen fibres and to restore hydration and
elasticity within the vaginal mucosa.
IntimaLase 2940nm nonablative  Deliver energy to the vaginal mucosa tissue in
Er:YAG a fast sequence of low-fluence laser pulse,
resulting in a nonablative heating that tighten
the vaginal canal via neocollagenesis and
remodelling.
Petit Lady 2940nm Er:YAG  Combines multiple micropulses with long-
pulse modes, enables deeper secondary
thermal effect and the controlled heating of
the target mucous membrane of the vaginal
wall.
Radiofrequency-based devices
ThermiVa Temperature-  Uses an S-shaped handpiece that tightens
controlled RF external and internal vulvovaginal tissue via
thermistor tip, which also controls heat
delivered to the skin.
ReVive Bipolar RF  Combined 3 RF frequency channels to
improve labial skin laxity and texture. It
ensures accurate energy delivery for safe and
painless treatments, broader effect and higher
energy absorption.
Viveve System Patented RF  Uses proprietary form of RF-based energy to
remodel collagen and restore the tissue in the
vaginal introitus.
Protégé Intima Focused RF  Allow collagen remodelling treatments at high
energy levels without temperatures reaching
the skin‟s surface.
Pelleve Monopolar RF  Denature the dermal collagen, inducing
remodelling and tissue tightening and
subsequent reduction or redundant skin in the
area.
3
Figure 1: Laser-based devices
Figure 2: Radiofrequency-based devices
4. METHODS
4.1. Searching
Electronic databases were searched through the Ovid interface:
 Ovid MEDLINE® In-process and other Non-indexed citations and Ovid
MEDLINE® 1946 to present
 EMBASE – 1996 to August 2017
 EBM Reviews - Cochrane Central Register of Controlled Trials – August 2017
 EBM Reviews - Cochrane Database of Systematic Reviews - 2005 to August
2017
 EBM Reviews - Health Technology Assessment – 4th Quarter 2016
 EBM Reviews – NHS Economic Evaluation Database 1st Quarter 2016
Searches were also run in PubMed. Google was used to search for additional
web-based materials and information. Additional articles were identified from
reviewing the references of retrieved articles. Last search was conducted on 4
August 2017.
4
Appendix 1 shows the detailed search strategies.
4.2. Selection
A reviewer screened the titles and abstracts against the inclusion and exclusion
criteria and then evaluated the selected full text articles for final article selection.
The inclusion and exclusion criteria were:
Inclusion criteria
Population Woman with vaginal laxity, vaginal relaxation syndrome

Interventions i. Surgical procedure for vaginal tightening : Open
surgery, laser surgery
ii. Non-surgical (instrumental) for vaginal tightening:
Radiofrequency devices
Comparators Sham treatment/pelvic floor exercise/no comparator
Outcomes i. Effectiveness/Efficacy: Vaginal anatomy (structure,
tone and length), sexual function, sexual satisfaction,
sexual gratification
ii. Safety: Adverse events, complications
iii. Psychological/Social/Ethical: Acceptance, religious
iv. Organizational: Guidelines, recommendations
v. Economic: Cost-effectiveness, cost-analysis
Study design Health Technology Assessment (HTA) reports,
Systematic review (SR) and Meta-analyses, Randomised
Controlled Trials (RCT), Non-randomised controlled trials
(NRCT), cohort studies, cross-sectional studies, case
control studies, case series.
Exclusion criteria
Study Studies conducted in animals, narrative reviews, case

design reports, pilot studies
Non English full text articles
Relevant articles were critically appraised using Critical Appraisal Skills

Programme (CASP) and graded according to US/Canadian preventive
services task force (Appendix 2). Data were extracted and summarised in
evidence table as in Appendix 3.
4.3. Risk of bias

One of the tools that are being used by MaHTAS to assess the risk of bias is
the CASP checklist which consists of eight critical appraisal tools designed for
SR, RCT, cohort studies, case control studies, economic evaluations,
diagnostic studies, qualitative studies, and clinical prediction rule. This is
5
achieved by answering a pre-specified question of those criteria assessed and
assigning a judgement relating to the risk of bias as either:
+ Indicates YES (low risk of bias)

? indicates UNKNOWN risk of bias
- Indicates NO (high risk of bias)
For RCT, Cochrane Risk of Bias Assessment tool was used to assess the risk
of bias.
5. RESULTS AND DISCUSSION
A total of 186 titles were identified through the Ovid interface and PubMed.
There were sixteen articles included in this review; one RCT, one cohort study,
six pre and post intervention studies, four cross sectional studies, three policy
documents and one guideline as shown in Figure 3. However, there was no
retrievable evidence from the scientific databases on cost-effectiveness of this
technology. The studies retrieved and included in this review were conducted
in United States, Iran, Chile, Turkey, Argentina, Venezuela, Japan, Italy and
Portugal.
6
Number of records identified Number of additional records
through electronic databases identified from other sources
searching (n=186) (n=18)
Number of records after duplicates removed (n=181)
Number of records Number of records

screened (n=181) excluded (n=147)
Number of full-text Number of full-text

articles assessed articles excluded
for eligibility (n=34) (n=18) with
reasons:
- Irrelevant study design
(n=10)
- Irrelevant intervention (n=2)
- Irrelevant population (n=6)
Number of full-text articles

included in qualitative
synthesis (n=16)
Figure 3: Flow chart of study selection
7
5.1. STUDY DESCRIPTION
5.1.1. Risk of bias
Risk of bias assessment in the included studies are summarised according to

their study design as below.
Allocation concealment
Blinding of participants
Incomplete outcome
Adequate sequence
Free of other bias

Free of selective
data addressed
and personnel
Criteria assessed
generation
reporting
Krychman et al.
+ ? + + ? ?
Figure 4a: Assessment of risk of bias of RCT (Cochrane)
Confounding
Follow-up of
Selection of
Criteria assessed
accurately
accurately
measured
measured
Exposure
Outcome
subjects
factors
cohort
Jamali S et al.
+ + + ? +
Figure 4b: Assessment of risk of bias of cohort (CASP)
8
Sekiguchi Y et al.
Vicariotto F et al.
Moore RD et al.
Pardo JS et al.
Abedi P et al.
Lalji S et al.
Criteria assessed
Question or objective clearly stated?

+ + + + + +
Eligibility/selection criteria for study population
clearly described? + + + + + +
Were participants representative for those who
would be eligible for the test/ service/
intervention in the population of interest? + + + + + +
Were all eligible participants that met the
prespecified entry criteria enrolled? + + + + + +
Sample size sufficiently large to provide
confidence in findings? ? ? ? ? - ?
Test/service/intervention clearly described and
delivered consistently? + + + + + +
Outcome measures prespecified, valid,
reliable, and assessed consistently? + + + + + +
People assessing the outcome measures
blinded to participants exposure/
interventions? - - - - ? ?
Loss to follow-up after baseline 20% or less?
Loss to follow-up accounted for in the
analysis? + + - + + +
Statistical methods examine changes in
outcome measures from before to after
intervention? p value? + + + + + +
Outcome measures taken multiple times
before and after intervention? Use interrupted
time-series design? + + - - ? ?
If intervention conducted at group level, did
statistical analysis take into account of
individual level data to determine effects at ? ? + - - -
group level?
Figure 4c: Assessment of risk of bias of pre-post studies with no

control (NIH)
9
5.2. EFFICACY / EFFECTIVENESS
Seven studies reported the effectiveness of surgical method for vaginal
tightening, of which one was cohort study, three pre and post intervention
studies and three cross sectional studies.
Four studies reported the effectiveness of non-surgical method of vaginal

tightening, of which one was RCT and three were pre and post intervention
studies.
5.2.1. Surgical method
5.2.1.1. Open surgery

Abedi et al. (2014) conducted a pre and post intervention study to evaluate the
effect of selective vaginal tightening (colpoperineoplasty) on sexual functions
in women of reproductive age with vaginal laxity in Iran. Between May 2011
and March 2012, 79 women aged between 15 and 45 with vaginal laxity were
enrolled in this study. All participants were requested to complete a
sociodemographic questionnaire and a Female Sexual Function Index (FSFI)
preoperatively and six months after surgery. The FSFI contained 19 questions
including two questions in the libido domain, four questions in the sexual
arousal area, four questions in the lubrication area, and three questions each
for orgasm, sexual satisfaction and pain. A five-point Likert scale was used for
scoring. Vaginal tightening was performed under general anaesthesia by one
gynaecologist. Participants were followed up at one week, one month, two
months, three months and six months after surgery. The average total FSFI
score increased from 24.19 ± 3.09 to 26.92 ± 3.41 (p<0.001) after surgery.
The vaginal tone was examined by a gynaecologist after surgery; 77 (97.5%)
women had tight vagina and only two women (2.5%) claimed that they felt little
change compared to before surgery. The scores for libido, arousal and orgasm
and satisfaction domain were improved significantly six months after surgery
(p<0.001). The authors concluded that elective vaginal tightening had a
positive effect on the sexual function in women.12, level II-2
Jamali et al. (2014) continued the study done by Abedi et al. to evaluate the
long term effect of colpoperineoplasty on sexual function among women with
vaginal laxity. All participants were asked to return to the clinic 18 months
after surgery for check up. Each participant was asked to complete FSFI
questionnaire again during the check up. A total of 76 women completed the
18 months follow up. The total FSFI score increased from 26.92 ± 3.41 to
32.61 ± 1.32 (p<0.001) 18 months after surgery (Table 2). All aspects of
sexual function were improved significantly compared to the sixth month of the
study. The authors concluded that the long term effect of colpoperineoplasty in
women who suffer from vaginal laxity is promising.13, level II-2
10
Table 2: Sexual function domains in study women preoperatively, six and 18
months after colpoperineoplasty.
Moore et al (2014) conducted a pre and post intervention study to evaluate the
sexual function outcomes by validated Pelvic Organ Prolapse/Urinary
Incontinence Sexual Questionnaire-12 (PISQ-12) in a group of women
presenting for vaginal rejuvenation surgery. Seventy eight women aged
between 25 and 62 with vaginal laxity were enrolled in this study. All patients
had posterior colpoperineoplasty and were required to complete PISQ-12
questionnaire preoperatively and six months postoperatively. The PISQ-12
questionnaire measures three domains which were behavioral-emotive,
physical and partner-related. A total of 60 patients had completed both pre
and postoperative questionnaires. The overall sexual function (total PISQ
score) improved significantly from 30.3 ± 6.6 before surgery to 38.2 ± 5.2 after
surgery. Overall sexual satisfaction improved as well as subcategories of
increased sexual excitement during intercourse, decreased negative emotional
reactions and overall increase in intensity of orgasms. Sexual excitement
increased by 18.4% after the surgery (preoperatively 58.3% versus 76.7%,
p=0.032). Women were less likely to report negative emotional reactions after
the surgery (preoperatively 31.7% versus 5.1%, p<0.001). All individual scores
statistically improved except in three categories in which there was no change
(Q1-desire, Q5-pain, and Q11-partner premature ejaculation).14, level II-2
Pardo et al. (2006) conducted a pre and post intervention study to report the
results of colpoperineoplasty in enhancing the sensation of vaginal tightness
and sexual gratification in woman. Between November 2003 and October
2004, a total of 53 women aged between 30 and 66 with sexual dissatisfaction
and a sensation of wide vagina were selected for colpoperineoplasty at Las
Condes Clinic, Chile. All participants had a site-specific anterior and posterior
repair. The participants were requested to answer identical questionnaires
before and six months after surgery to assess the participants‟ satisfaction.
Compared to the situation prior to surgery, 35 women (66%) experienced a
great improvement in sexual life. Fifty women (94%) said they were able to
reach orgasm and 51 women (96%) felt an adequate tightening of the vagina.
Two patients (4%) regretted having undergone surgery. The authors
concluded that colpoperineoplasty seems to improve symptoms and enhance
11
sexual gratification in a majority of the women with sensation of wide vagina.15,
level II-2
Ulubay et al. (2016) conducted a cross sectional study to investigate the

safety, efficiency and outcomes of PP in woman with the sensation of wide
vagina. Patient records of women presented with sensation of wide vagina and
treated with PP between January 2012 and September 2015 were reviewed.
Preoperative and postoperative genital hiatus length, perineal length, and total
vaginal length in patients treated with PP were recorded. Preoperative and
postoperative genital hiatus, perineal length and total vaginal length were 4.62
and 3.18 (p<0.01), 3.06 and 4.04 (p<0.01), and 9.43 and 9.43 (p=0.882),
respectively. The genital hiatus measurements decreased by 40%
postoperatively, while perineal length measurement increased by 30%. 16,level II-3
Goodman et al. (2010) conducted a multicentre cross sectional study to

investigate outcomes of FGCS procedures, specifically LP, PP, VP and clitoral
hood reduction (RCH). Between January 2005 and May 2008, records of
patients undergoing FGCS were reviewed. Data were collected retrospectively
via questionnaires to analyze patients overall and sexual satisfaction.
Physician‟s data were collected from office and surgical records only on the
patients who returned the questionnaires. A total of 258 patients undergoing
341 separate procedures came from a group of 12 surgeons from ten centres
returned a completed survey. Patients were categorised into three groups;
vulvar work group (LP and/or RCH, n=177), vaginal work group (VP and/or
PP, n=47) and combined group (LP with VP/PP with or without RCH, n=34).
Enhancement of sexual function was noted in 64.7% of women and 35.7% of
their partners for LP/RCH, 86.6% of women and 83.4% of their partners for
VP/PP procedures, and 92.8% of women, 82.2% of their partners for
combined procedures. The authors suggested that FGPS procedures appear
to provide selected women increased comfort with their genitalia and
enhanced sexual pleasure.17, level II-3
5.2.1.2. Laser surgery

Gaviria et al. (2016) conducted a cross sectional study to evaluate the long
term efficacy of laser vaginal tightening (LVT). A total of 103 patients (aged 20
to 74) with vaginal relaxation syndrome and treated with a 2940nm Er:YAG
laser between June 2011 and May 2014 were included in this study. All
patients were required to complete the PISQ-12 questionnaire to assess the
sexual function prior to treatment and at follow up before the second session.
According to the patients‟ evaluation of the results, the average duration of
effect after the therapy was 16 months, with significant improvement of stress
urinary incontinence and prolapse. Majority of results (30%) persisted 18 to 24
months and the effect of the therapy starts to fade two years after the
treatment.18, level II-3
12
5.2.2. Non-surgical method
Krycman et al. (2017) conducted a RCT to evaluate the efficacy and safety of
surface-cooled, monopolar RF therapy for the treatment of vaginal laxity in the
VIVEVE I trial. This trial was a prospective, randomised, single-blinded, and
sham-controlled study conducted at nine centres in Canada, Spain, Italy and
Japan. Between January 2015 and November 2015, women presenting with
vaginal laxity were enrolled and randomised (2:1) to received RF therapy
(active [90 J/cm2] versus sham [1 J/cm2]) delivered to the vaginal tissue. The
primary efficacy outcome on vaginal laxity was assessed using the Vaginal
Laxity Questionnaire (VLQ). Secondary efficacy assessment of sexual function
was evaluated using the FSFI. A total of 174 randomised subjects received RF
therapy (active n=117, sham n=57). Six months after treatment, no vaginal
laxity was reported by 43.5% and 19.6% (p=0.002) subjects in the active and
sham groups, respectively. The minimally clinical important differences (MCID)
analyzed at six months shown an improvement of at least two points (on the
seven-point Likert scale) in 57 subjects (52.8%) in the active group and 17
(30.4%) in the sham group (p=0.006). The MCID Odd Ratio (OR) was 2.63
with 95% Confidence Interval (CI) (1.31, 5.27). The adjusted mean changes
on the FSFI total score were 4.16 and 2.36 for the active and sham groups,
respectively (adjusted difference=1.80; 95% CI=0.17, 3.43). The MCID for the
FSFI total score shown an improvement of at least 4.8 points in 46 subjects
(42.6%) in the active group and 14 (30.4%) in the sham group. The MCID OR
was 2.46 with 95% CI (1.06, 5.72). The study results showed statistically
significant improvements of self-reported vaginal laxity and overall sexual
function. The authors concluded that a single treatment of RF therapy was
found to be safe and associated with both improved vaginal laxity and
improved sexual function.19, level II-2
Sekiguchi et al. (2013) conducted a pre and post intervention study to report
the long-term effectiveness of a single nonsurgical procedure with RF energy
for vaginal laxity. Between January and December 2011, 30 Japanese women
with vaginal introital laxity were enrolled in this study. A single RF treatment
(90 J/cm2) was performed on each participants. All participants were required
to complete questionnaires before the treatment and at one, three, six and 12
months follow ups. The 12 months outcome assessments included VLQ and
FSFI. Sexual function improved significantly throughout six months.
Participants reported decreased vaginal laxity within the first month after the
procedure (p<0.001). The responses peaked after one month and the
effectiveness was sustained through 12 months (p<0.001). Mean FSFI total
score was 22.4 ± 6.7 before treatment and then improved to 26.0 ± 5.8 at six
months (p=0.002). In the 22 of 30 participants (73.3%) remaining evaluable at
12 months, the mean was 26.0 ± 5.2 (p=0.08). The authors concluded that a
single RF procedure for vaginal introital laxity achieved significant and
sustainable 12 months effectiveness with respect to improved integrity at the
vaginal introitus.20, level II-2
13
Vicariotto et al. (2016) conducted a pre and post intervention study to
investigate the safety and efficacy of a new low-energy dynamic quadripolar
radiofrequency (DQRF) device in women with vaginal laxity and vulvo-vaginal
atrophy (VVA) and genitourinary syndrome of menopause (GSM). Between
January and July 2015, 12 women with vagina laxity and 13 women with
VVA/GSM were enrolled in the vaginal laxity arm and VVA/GSM arm of the
study, respectively. Women in vaginal laxity arm underwent five 20 minutes
DQRF thermal treatment sessions every 14 ± 1 days. A vulvo-vaginal laxity
questionnaire (VVLQ) and PISQ-12 were used to assess urinary incontinence,
sexual gratification and the contribution of any concomitant pelvic organ
prolapse. There was a significant improvement in VVLQ mean scores
(p<0.005) and total PISQ-12 score (34.5 ± 6.8 versus 38.5 ± 6.1, p<0.005) at
the first assessment visit. The authors suggested that improvement in vaginal
laxity with DGRF treatment were rapid and persistent.21, level II-2
Lalji et al. (2017) conducted a pre and post intervention study to investigate
the efficacy and safety of a monopolar RF device for transvaginal treatment of
SUI and vulvo-vaginal laxity. A total of 27 women aged between 28 and 66
who experienced mild to moderate SUI and vaginal laxity were enrolled in this
study. All subjects were treated with monopolar radiofrequency device. The
treatment course consisted of three once-a-week sessions. Improvements
were evaluated by applying the International Consultation on Incontinence
Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and VLQ at one
month follow up. The outcome data and the results from ICIQ-UI SF and VLQ
were presented in Table 3. Improvement in treated conditions was reported
immediately after the last treatment session and was even more significant
after the one month follow up visit. Twenty six subjects (96.3%) with SUI
reported improvement of at least one level, with 15 subjects (55.6%) showed
improvement of two or more levels when comparing the baseline to the follow
up visit. For vaginal laxity, all subjects reported improvement of at least two
levels, with 23 subjects (85.2%) showed improvement of three or more levels
when compared baseline to the follow up visit.The VVLQ score increased from
2.19 ± 1.08 to 5.74 ± 0.76 one month after treatment.22, level II-2
Table 3: Changes in SUI and vulvo-vaginal laxity
14
5.3. SAFETY
Seven studies reported the safety of surgical method of vaginal tightening, of
which one was cohort study, three pre and post intervention studies and three
cross sectional studies.
Two studies reported the safety of non-surgical method of vaginal tightening,

of which one was RCT and one was pre and post intervention study.

Abedi et al. (2014) conducted a pre and post intervention study to evaluate the
effect of colpoperineoplasty in 79 women with vaginal laxity. Six months after
surgery, dyspareunia increased and lubrication decreased significantly
(p<0.001). Thirty seven (46.8%) women had dyspareunia most of the time, 14
(17.7%) seldom, 26 (32.9%) sometimes, one (1.3%) did not have any pain and
one (1.3%) always had dyspareunia.12, level II-2 However, a continued study by
Jamali et al. reported a significant improvement of dyspareunia and lubrication
(p<0.001) 12 months after surgery.13, level II-2
A pre and post intervention study by Moore et al. (2014) reported that in 60
women who received colpoperineoplasty, pain with intercourse subscores
were found to be no different from preoperatively to postoperatively. 14, level II-2
A pre and post intervention study by Pardo et al. (2006) reported the effect of
colpoperineoplasty in 53 women with vaginal laxity. Two women (4%)
experienced minimal surgical wound dehiscence (affecting the vagina and the
perineum) that resolved spontaneously.15, level II-2
Ulubay et al. (2016) investigate the safety of PP in 64 women with sensation of

wide vagina. The study reported that four (10%) patients experienced
dyspareunia during sexual intercourse at the introitus of the vagina. 16, level II-3
Goodman et al. (2010) conducted a multicentre cross sectional study in 258

women who received FGPS procedures. Of the patients who had LP/RCH,
8.5% felt they had a complication of surgery, while 16.6% of the women who
had undergone VP/PP and 18.2% of the women who had undergone a
combined procedure reported a complication. The complication percentages
from physician‟s perspective were 6%, 25% and 18% respectively. The
complications reported in patients underwent VP/PP procedure were
dyspareunia (2), excessive postoperative bleeding (2), vagina too tight (2),
prolonged healing and excessive pain (1) and infection (1). The complication
percentage from physician‟s perspective for VP/PP procedure were 23.4%
(11/47). Among the complication reported were rectal perforation (1), "felt
sutured inside" (1), bleeding with first coitus (1), excessive postoperative pain
15
(1), inadequate tightening (1), introital narrowing (1) and urinary urgency (1).17,
level II-3

Gaviria et al. (2016) evaluate the long term efficacy of LVT (Er:YAG laser) in
103 women with vaginal relaxation syndrome. Adverse effects reported were
limited to mild and transient edema and a tolerable heating sensation in a few
cases.18, level II-3

A RCT by Krychman et al. (2017) evaluated and compared the safety of
monopolar RF and sham treatment in 186 women with vaginal laxity.
Treatment-emergent adverse events (TEAE) were reported by 13 (11.1%) and
seven (12.3%) subjects in the active and sham groups, respectively. Most
frequently reported related TEAE was vaginal discharged, which occurred in
three (2.6%) and two (3.5%) subjects in the active and sham groups,
respectively.19, level II-1
Sekiguchi et al. (2013) conducted a pre and post intervention study to report
the long term effectiveness of a single RF therapy in 30 women with vaginal
laxity. Seven (23%) participants reported sporadic discomfort or pain with one
(3%) reported excessive but sporadic pain. One case each of mild vaginal
leukorrhea and mild lower abdominal pain were also reported.20, level II-2
5.4. PSYCHOLOGICAL / SOCIAL / ETHICAL

Four cross sectional studies reported the psychological, social and ethical
issues of surgical method of vaginal tightening.
One RCT and two pre and post intervention studies reported the psychological
and social issues of non-surgical method of vaginal tightening.

Ulubay et al. (2016) investigate the outcome of PP in 64 women with
sensation of wide vagina. At least six months after surgery, a telephone survey
was used to determine postoperative patient and male partner satisfaction
rates. A total of 38 patients completed the survey. At the six months follow-up,
patient's reported satisfaction rate was 87.9% ± 6.85, while reported partner's
satisfaction rate was 92.6% ± 7.6. The number of patients who would
recommend the procedure to friends was also high (87.9% ± 6.8).16, level II-3
Goodman et al. (2010) conducted a multicentres cross sectional study in 258

women who received FGPS procedures. The reasons for surgery from
patient‟s and physician‟s perspective were broken down into five categories
16
which were functional, cosmetic appearance, the perception of being
abnormal, vaginal relaxation and sexual pleasure, and partner‟s sexual
pleasure. Functional and cosmetic appearance issues (75.7%) predominate in
the LP/RCH group, while sexual issues predominate both VP/PP group
(58.3%) and combined procedures group (56.8%). The physician‟s perspective
regarding the reasons their individual patients underwent surgery parallel that
of their patients in all of the groups. The overall satisfaction rates were 97.2%
for LP/RCH reduction, 83.0% for VP/PP procedures and 91.2% for combined
procedures. Enhancement of sexual pleasure was noted in 64.7% of women
and 35.7% of their partners for LP/RCH, 86.6% of women and 83.4% of their
partners for VP/PP procedures, and 92.8% of women and 82.2% of their
partners for combined procedures.17, level II-3

Gaviria et al. (2016) conducted a cross sectional study to evaluate the long
term efficacy of Er:YAG laser treatment in 103 patients with vaginal relaxation
syndrome. Telephone interviews were obtained asking patients to complete
Laser Vaginal Tightening (LVT) questionnaire and self-assess the efficacy of
the IntimaLase® laser vaginal tightening treatment based on six, 12, 18, 24
and 36 months follow ups. A total of 60 patients (58.3%) participated in the
telephone interview. Results showed that 58.0% (35/60) of participants highly
satisfied with the treatment while 11.6% (7/60) were poorly satisfied with
limited or no treatment outcomes. Further results also show that 83.3% (50/60)
of participants would be willing to repeat the treatment and 90% (54/60) would
also recommend the treatment.18, level II-3

A RCT by Krychman et al. (2017) assessed the psychological distress in 186
women who received monopolar RF or sham treatment. The psychological
distress was evaluated using the revised Female Sexual Distress Scale
(FSDS-R). Results on the sexual distress scale (FSDS-R total score) showed
a borderline significant findings of less distress for the active group compared
with the sham group (p=0.056). The MCID for the FSDS-R total score shown
an improvement of at least 5.9 points in 58 subjects (54.2%) in the active
group and 19 (33.9%) in the sham group. The MCID OR was 2.33 with 95% CI
(1.07, 5.07).19, level II-1
Sekiguchi et al. (2013) reported the changes in psychological distress

associated with sexual satisfaction in 30 premenopausal women who received
a single RF therapy for vaginal laxity. The outcomes were measured by using
FSDS-R, VLQ and Sexual Satisfation Questionnaire (SSQ). Significant
improvement in sexual satisfation as reported on the SSQ were perceived at
each follow up assessment in 13 of the 17 (76.5%) subjects who expressed
decreased satisfation at study entry. The pretreatment mean score of
1.29±0.17 improved to 2.71±0.66 at month 6 (p<0.001). Distress related to
sexual activity decreased significantly, baseline FSDS-R mean score of 15.8 ±
17
11.7 improved to 9.8 ± 8.0 at one month and was sustained throughout 12
months.20, level II-2
Lalji et al. (2017) evaluate the efficacy of monopolar RF when used to treat 27
women with SUI and vulvo-vaginal laxity. Patient‟s satisfaction was assessed
using a satisfaction questionnaire after the last treatment and at the one month
follow up. During the follow-up visit, 89% (24/27) of the patients “agreed” or
“strongly agreed” that their SUI condition improved, and 93% (25/27) of the
patients “agreed” or “strongly agreed” that their gratification during intercourse
improved.22, level II-2
5.4.3. Ethic
Vieira-Baptista et al. (2017) conducted a cross sectional study to assess the
medical doctors and medical students' opinion regarding the evidence and
ethical background of the performance of vulvovaginal aesthetic procedures
(VVAPs). Between September 2015 and February 2016, an online survey was
sent to the target population via email and posted in the websites of medical
societies and in specific social network groups (exclusively for doctors and
medical students). A total of 664 questionnaires were obtained from
participants. Majority of the respondents were specialist, 37.0% (246/664),
followed by students, 34.2% (227/664) and residents, 28.8% (191/664). Most
participants considered that there is never or there rarely is a medical reason
to perform vulvar whitening (85.9% [502/584]), hymenoplasty (72.0%
[437/607]), mons pubis liposuction (71.6% [426/595]), "G-spot" augmentation
(71.0% [409/576]), labia majora augmentation (66.3% [390/588]), labia minora
augmentation (58.3% [326/559]) or laser vaginal tightening (52.3% [313/599]).
Gynecologists and specialists were more likely to consider that there are no
medical reasons to perform VVAPs; the opposite was true for plastic surgeons
and students/residents. Plastic surgeons and students/residents were less
likely to raise ethical objections, while the opposite was true for gynecologists
and specialists. Most considered that VVAPs could contribute to an
improvement in self-esteem (92.3% [613/664]), sexual function (78.5%
[521/664]), vaginal atrophy (69.9% [464/664]), quality of life (66.3% [440/664]),
and sexual pain (61.4% [408/664]). The majority agreed, at least partially, that
all women should be evaluated by a psychiatrist/sexologist prior to surgery
(552/664 [83.1%]), if performed, these surgeries should take place in public
hospitals (381/664 [57.3%]) and advertising them should be forbidden
(339/664 [51.0%]). The authors concluded that medical doctors and students
acknowledge the lack of evidence and scientific support for the performance of
VVAPs. However, most do not raise ethical objections about them, especially
if they are students or plastic surgeons, or if they have had or have considered
having plastic surgery.23, level II-3
In Malaysia, the appropriateness or legality of vaginal tightening according to

Islamic Law has not yet been discussed by Majlis Fatwa Kebangsaan.
Cosmetic surgery is permissible in Islam provided it is used to treat a
18
deformed organ where the surgery will offer a better quality of life. However,
such surgery is not permissible if it is used for the mere purpose of
beautification, sexual satisfaction and altering the creation of Allah. 24, 25
5.5. ORGANIZATIONAL
Three policy documents and one guideline were retrieved on the
organizational issues for vaginal tightening.
5.5.1. Guidelines / Recommendations

The American College of Obstetricians and Gynaecologists (ACOG) has
issued a policy statement in 2008 on the role of the obstetrician and
gynaecologist in cosmetic procedures. Among the recommendations were:
 For the physician offering cosmetics services, the health, well being and
safety of the patients must be paramount, and the obstetrician and
gynaecologist must be knowledgeable of the ethics of patient
counselling and informed consent.
 Inquiries regarding cosmetics products, services and procedures must
come from the patient and the patient should feel no pressure and
obligation to purchase or undergo any cosmetics services.
 The obstetrician and gynaecologist is responsible to engage patients
considering cosmetic services in dialogue that supports the individual‟s
effort to analyze and respond to societal or marketing pressure toward
an often unattainable aesthetic ideal.
 Special care must be taken when patients are considering procedures
in an effort to enhance sexual appearance or function, as female sexual
function response has been shown to be an intricate process
determined predominantly by brain function and psychosocial factors,
not by genital appearance. Such procedures are not medically
indicated, and their safety and effectiveness have not been
documented.26
The Royal Australian and New Zealand College of Obstetricians and

Gynaecologists released a policy statement in 2016 on vaginal rejuvenation
and cosmetic vaginal procedures. Among the recommendations were:
 Medical practitioners performing any vaginal surgery should be
appropriately trained.
 Obstetricians and gynaecologists should have a role in educating
women that there are a large number of variations in the appearance of
normal female external genitalia and that there are normal physiological
changes over time, especially following childbirth and menopause.
should be assessed thoroughly and the reasons for such a request
assessed carefully. Sexual counselling is also recommended for
patients requesting surgery that is purported to enhance gratification.
 Doctors who perform these procedures should not promote or advertise
that these procedures enhance sexual function.
19
 The College strongly discourages the performance of any surgical or
laser procedure that lacks current peer reviewed scientific evidence
other than in the context of an appropriately constructed clinical trial. 27
The Clinical Practice Gynaecology Committee and the Ethics Committee has
issued a policy statement in 2013 to provide Canadian gynaecologist with
evidence based direction for FGCS in response to increasing request of
vaginal and vulvar surgeries that fall well outside the traditional realm of
medically-indicated reconstructions. The recommendations were:
 The obstetrician and gynaecologist should play an important role in
helping women to understand their anatomy and to respect individual
variations
 For women who present with requests for vaginal cosmetic procedures,
a complete medical, sexual and gynaecologic history should be
obtained and the absence of any major sexual or psychological
dysfunction should be ascertained. Any possibility of coercion or
exploitation should be ruled out.
 Counselling should be a priority for women requesting FGCS. Topics
should include normal variation and physiological changes over the
lifespan, as well as the possibility of unintended consequences of
cosmetic surgery to the genital area. The lack of evidence regarding
outcomes and the lack of data on the impact of subsequent changes
during pregnancy or menopause should also be discussed and
considered part of the informed consent process.
 There is little evidence to support any of the FGCS in terms of
improvement to sexual satisfaction or self-image. Physicians choosing
to proceed with these cosmetic procedures should not promote these
surgeries for the enhancement of sexual function and advertising of
FGCS procedures should be avoided.
 Physicians who see adolescents requesting female genital cosmetic
surgery require additional expertise in counselling adolescents. Such
procedures should not be offered until complete maturity including
genital maturity, and parental consent is not required at that time.
 Non-medical terms, including but not restricted to vaginal rejuvenation,
clitoral resurfacing, and G-spot enhancement, should be recognized as
marketing terms only, with no medical origin; therefore they cannot be
scientifically evaluated.28
The Royal Australian College of General Practitioners (2015) provides a

guideline to help inform general practitioners (GP) and health professionals
about FGCS and how to manage women requesting for referral for FGCS.
Summary of the recommendations were:
 Female genital cosmetic surgery incidence is climbing. Informed GPs
can reduce unnecessary anxiety regarding vulval/genital anatomy,
thereby deflecting a climb in FGCS.
20
 Patient examination should be performed by the GP or referred to a
doctor experienced in women‟s health. This is an opportunity to educate
female patients about genital anatomy.
 It is important to consider mental health and relationship abuse issues
and refer accordingly.
 Educate patients about genital diversity, using tools such as the online
resource Labia Library and the publication Femalia, and possible
complications of surgery.
 It is recommended GPs initially refer patients for a gynaecological
assessment.
 If the patient is younger than 18, they should be referred to a specialist
adolescent gynaecologist.11
5.6. COST / COST-EFFECTIVENESS / FEE

There was no retrievable evidence on the cost-effectiveness of surgical and
non-surgical method for vaginal tightening. In Malaysia, the fee of surgical
procedures for vaginal rejuvenation range between RM12,000 and RM15,000,
while the fee of non-invasive laser procedures range between RM2,600 and
RM10,000.30,31
5.7. LIMITATIONS
This technology review has several limitations. The selection of studies was
done by one reviewer. Although there was no restriction in language during
the search but only English full text articles were included in this review. Most
of the studies retrieved and included in this review have small sample size and
no control group, with the exception of one study which have sham treatment
group. The study outcomes were mainly assessed by using questionnaires.
6. CONCLUSION
6.1. Effectiveness
Surgical method
There was limited fair level of retrievable evidence to show that surgical
vaginal tightening may increase sexual function to certain extend. These
effects can last up to 18 months with open surgery and for 24 months with
laser surgery. However most of the studies retrieved have small sample size,
no randomised with short-term follow up.
Non-surgical method
There was limited fair level of retrievable evidence to show that non-surgical
vaginal tightening may increase sexual function in women with vaginal laxity.
These effects are felt immediately and sustainable up to 12 months. However
most of the studies retrieved have small sample size, no randomised with
short-term follow up.
21
6.2. Safety
Surgical method
adverse side effects or complications such as dyspareunia (4.3-46.8%),
wound dehiscence (4%), bleeding/haematoma (2.1%), failed to achieve
desired results ( 2.1%) and decrease in vaginal lubrications. When laser was
used, patients do experience transient oedema and a tolerable heat
sensation.
Non-surgical method
adverse side effects or complications such as sporadic pain (23.3%) and
vaginal discharge (2.6%).
6.3. Psychological/Social/Ethical
Surgical method
There was limited fair level of retrievable evidence to suggest this method for
vaginal rejuvenation has variable satisfactory rate among the patient and the
partner/s. The satisfaction rates among women were range between 11.6% to
87.9%. The partner/s reported a better satisfaction rate (92.6%).
Non-surgical method
There was limited fair level of retrievable evidence to suggest that this
method was tolerable and satisfactory to most women. The satisfaction rate
with these procedures was range between 76.5 to 93.0%. It was also noted
that the distress related to the sexual activity among these women was
significantly reduced. However the assessment carried out was subjective
and short term effect.
Ethic
There was limited fair level of retrievable evidence to suggest that medical
doctors and medical students acknowledge the lack of evidence and
scientific support for vaginal tightening, but most did not raise ethical
objections about them.
6.4. Organizational
Three policy documents and one guideline were retrieved on the
organizational issues for vaginal tightening:
 Counselling should be a priority for women requesting for cosmetic
procedures.
 Women who wish to undergo these procedures should be given a
thorough explanation by the practitioner/obstetrician and gynaecologist.
22
 Practitioners/Obstetricians and gynaecologists should have a role in
educating women that there are a large number of variations in the
appearance of normal female external genitalia and that there are normal
physiological changes over time, especially following childbirth and
menopause.
should be assessed thoroughly and the reasons for such a request
assessed carefully. Sexual counselling is also recommended for patients
requesting surgery that is purported to enhance gratification.
 Medical practitioners performing any vaginal surgery should be
appropriately trained to perform the procedures undertaken.
 Medical practitioners who perform these procedures should not promote or
advertise that these procedures to enhance sexual function per se.
6.5. Cost/Cost-effectiveness/ Fee

There was no retrievable evidence on the cost-effectiveness of surgical and
non-surgical method for vaginal tightening. In Malaysia, the fee of surgical
procedures for vaginal rejuvenation range between RM12,000 and
RM15,000, while the fee of non-invasive laser procedures range between
RM2,600 and RM10,000.
23
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medical students think? Rev Bras Ginecol Obstet. 2017;39(8):415-423.
24. Jabatan Mufti Negeri Selangor. Hukum menjalani rawatan estetik dan
pembedahan plastik di sisi islam. 2015. Available from:
http://www.muftiselangor.gov.my/fatwa-personalisation/fatwa-
tahunan/keputusan-fatwa-xwarta/2015/629-hukum-menjalani-rawatan-
estetik-dan-pembedahan-plastik-di-sisi-islam Accessed on 06.09.2017
25
25. Abdul Basit AR. Pembedahan kosmetik. Konvensyen Fiqh Perubatan.
2012. Available from
http://papisma.org/nota/fekah/Pembedahan%20Kosmetik%20-
%20HSB%20Kedah%20200912.pdf Accessed on 06.09.2017
26. American College of Obstetricians and Gynecologists. The role of the
obstetrician gynecologist in cosmetic procedures [ACOG policy
statement]. 2008. Available from https://www.acog.org/-
/media/Statements-of-
Policy/Public/sop85.pdf?dmc=1&ts=20171016T0337325907 Accessed on
06.09.17
27. The Royal Australian and New Zealand College of Obstetricians and
Gynaecologists. Vaginal 'rejuvenation', laser ablation for benign conditions
and cosmetic vaginal procedures. 2016. Available from
https://www.ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-
MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical
%20-%20Gynaecology/Vaginal-rejuvenation,-laser-and-cosmetic-
procedures-(C-Gyn-24)-Amended-July-2016.pdf?ext=.pdf Accessed on
06.09.2017
28. Shaw D, Lefebvre G, Bouchard C et al. Female Genital Cosmetic Surgery.
J Obstet Gynaecol Can. 2013;35(12):1108-1112.
29. Balakrishnan N. Laser treatments for vaginal rejuvenation are getting a lot
more popular in Malaysia. 2017. Available from
http://says.com/my/news/malaysia-is-becoming-very-popular-for-designer-
vagina-procedures Accessed on 16.09.2017
30. Su-lyn B. Designer vagina fad hits Malaysian middle class. 2017. Available
from http://www.themalaymailonline.com/malaysia/article/designer-vagina-
fad-hits-malaysian-middle-class#o11bpxOlxVvLpACe.97 Accessed on
16.09.2017
26
8. APPENDIX
8.2. Appendix 1: LITERATURE SEARCH STRATEGY
Ovid MEDLINE® In-process & other Non-Indexed citations and

OvidMEDLINE® 1946 to present
1. PREGNANCY COMPLICATIONS/
2. (pregnancy adj1 complication).tw.
3. vaginal laxity.tw.
4. vaginal relaxation.tw.
5. wide vagina.tw.
6. vaginal tightening.tw.
7. vaginal rejuvenation.tw.
8. SURGERY, PLASTIC/
9. cosmetic surgery.tw.
10. esthetic surger*.tw.
11. (plastic adj1 surgery).tw.
12. RECONSTRUCTIVE SURGICAL PROCEDURES/
13. reconstructive surgery.tw.
14. cosmetic reconstructive surgery.tw.
15. reconstructive surgical procedure.tw.
16. Vaginoplasty.tw.
17. Labiaplasty.tw.
18. Perineoplasty.tw.
19. Hymenoplasty.tw.
20. COSMETIC TECHNIQUES/
21. (cosmetic adj1 techni*).tw.
22. Plastic vaginal surgery.tw.
23. PULSED RADIOFREQUENCY TREATMENT/
24. (pulsed radiofrequency adj1 treatment).tw.
25. LASER THERAPY/
26. (laser adj1 (ablation or kni#e or scalpel or surger* or treatment or therapy or
vaporization or nonablative)).tw.
27. ELECTROSURGERY/
28. electrosurger*.tw.
29. Energy based device.tw.
30. 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20
or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29
31. 1 or 2 or 3 or 4 or 5
32. 30 and 31
27
OTHER DATABASES
EBM Reviews - Cochrane
Central Register of Controlled
Trials
EBM Reviews - Cochrane Same MeSH, keywords, limits used as per
database of systematic reviews MEDLINE search
EBM Reviews - Health
Technology Assessment
EBM Reviews – NHS
Economic Evaluation Database
PubMeD
((((vaginal relaxation[Title/Abstract]) OR vaginal laxity[Title/Abstract]) OR wide
vagina[Title/Abstract])) AND ((((((((((((((((((((vaginal tightening[Title/Abstract]) OR
cosmetic surger*[Title/Abstract]) OR esthetic surger*[Title/Abstract]) OR plastic
surger*[Title/Abstract]) OR Vaginal rejuvenation[Title/Abstract]) OR
reconstructive surgery[Title/Abstract]) OR cosmetic reconstructive
surgery[Title/Abstract]) OR reconstructive surgical procedure[Title/Abstract]) OR
vaginoplasty[Title/Abstract]) OR labiaplasty[Title/Abstract]) OR
perineoplasty[Title/Abstract]) OR cosmetic techni*[Title/Abstract]) OR plastic
vaginal surgery[Title/Abstract]) OR radiofrequency[Title/Abstract]) OR laser
therapy[Title/Abstract]) OR laser surger*[Title/Abstract]) OR laser
treatment[Title/Abstract]) OR laser vaginal tightening[Title/Abstract]) OR
electrosurgery[Title/Abstract]) OR energy based device[Title/Abstract])
28
8.2. Appendix 2
DESIGNATION OF LEVELS OF EVIDENCE
I Evidence obtained from at least one properly designed randomised

controlled trial.
II-I Evidence obtained from well-designed controlled trials without

randomization.
II-2 Evidence obtained from well-designed cohort or case-control analytic

studies, preferably from more than one centre or research group.
II-3 Evidence obtained from multiple time series with or without the
intervention. Dramatic results in uncontrolled experiments (such as the
results of the introduction of penicillin treatment in the 1940s) could also
be regarded as this type of evidence.
III Opinions or respected authorities, based on clinical experience;

descriptive studies and case reports; or reports of expert committees.
SOURCE: US/CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris

2001)
29
Appendix 3
Evidence Table : Efficacy
Question : Is surgical and non-surgical method effective for vaginal tightening?
Length
Number of
of follow
Bibliographic Study patients and Outcome measures/ General
LE Intervention Comparison up (if
citation Type / Methodology patient Effect size comments
applicab
characteristics
le)
1. Abedi P, Pre and post intervention study II-2 n=79 Colpoperine - 6 months  The average total FSFI score
Jamali S, oplasty increased from 24.19 ± 3.09 to
Tadayon M et Objective: Mean age: 26.92 ± 3.41 (p<0.001) after
al. To evaluate the effect of selective 34.02 ± 5.3 surgery.
Effectiveness vaginal tightening on sexual years  The scores for libido, arousal and
of selective functions in women of reproductive orgasm and satisfaction domain
vaginal age with vaginal laxity in Iran. Married woman were improved significantly 6
tightening on with vaginal months after surgery.
sexual function Method: laxity, literate  Sexual dysfunction decreased from
among Between May 2011 and March and aged 15-45 58 (73.4%) participants before
reproductive 2012, 86 women with vaginal laxity years. surgery to 37 (46.8%) after
22
aged women in in Jahrome, Iran were enrolled in surgery.

Iran with this study. All participants were
vaginal laxity: a requested to complete a Author‟s conclusion:
quasi- sociodemographic questionnaire Sexual function was improved 6
experimental and a Female Sexual Function months after vaginal tightening. This
study. J Obstet Index (FSFI) preoperatively, and indicates that elective vaginal
Gynaecol Res. FSFI questionnaire 6 months after tightening had a positive effect on the
2014;40(2):526 vaginal tightening. The FSFI sexual function in women. However,
-531. contained 19 questions including the increase in dyspareunia and
two questions in the libido domain, decrease in lubrication may limit the
IRAN four questions in the sexual arousal application of this type of surgery.
area, four questions in the
lubrication area, and three
questions each for orgasm, sexual
satisfaction and pain. A five-point
Likert scale was used for scoring.
Participants were followed up at 1
week, 1 month, 2 months, 3 months
and 6 months after surgery.
Length
Number of
of follow
applicab
characteristics
le)
2. Jamali S, Prospective cohort study II-2 n=86 Colpoperino - 18  76 women completed the 18-month
Abedi P, plasty months follow up.
Rasekh A et al. Objective: Mean age:  The total score of sexual function
The long term To evaluate the long term effect of 34.02 ± 5.3 increased to 32.61 ± 1.32 after 18
effect of colpoperineoplasty on sexual years months (p<0.001).
elective function among women who  All aspects of sexual function were
colpoperineopl complained of vaginal laxity in Iran. Married woman improved significantly compared to
asty on sexual with vaginal the sixth month of the study.
function in the Method: laxity, literate
reproductive This was a continue study from and aged 15-45 Author‟s conclusion:
aged women in Abedi et al. All patients were years. The long term effect of
Iran. Int Sch required to recomplete the colpoperineoplasty in women who
Res Notices. questionnaire 18 months after suffer from vaginal laxity is promising.
23
2014;4: surgery. It seems that patient‟s dissatisfaction

912786. of sexual function can be a basis for
colpoperineoplasty.
IRAN
Length
Number of
of follow
applicab
characteristics
le)
3. Moore Pre and post intervention study II-2 n=78 Posterior - 6 months  60 patients had completed both pre
RD, Miklos JR, colpoperineo and postoperative questionnaires.
Chinthakanan Objective: Mean age: 43.6 plasty/vagino  The overall sexual function (total
O. Evaluation To evaluate the sexual function (range 25 to 62) plasty PISQ score) improved significantly
of sexual outcomes by validated Pelvic Organ after surgery (preoperative 30.3±6.6
function Prolapse/Urinary Incontinence Women with vs. postoperative 38.2±5.2,
outcomes in Sexual Questionnaire-12 (PISQ-12) chief complaint p<0.001).
women compared between preoperative of vaginal  All individual scores statistically
undergoing and postoperative values in a group laxity/looseness improved except in 3 categories in
vaginal of women presenting for vaginal causing sexual which there was no change (Q1-
rejuvenation/va rejuvenation surgery. dysfunction and desire, Q5-pain, and Q11- partner
ginoplasty desiring vaginal premature ejaculation).
procedures for Method: rejuvenation  Overall sexual satisfaction improved
24
symptoms of Sexual function outcomes were surgery, age as well as subcategories of

vaginal analyzed in a group of women more than 18, increased sexual excitement during
laxity/decrease presenting for vaginal and clinically intercourse and overall increase in
d vaginal rejuvenation/vaginoplasty confirm vaginal intensity of orgasms.
sensation procedures for a chief complaint of laxity on exam.  Women who reported always and
utilizing vaginal laxity and decreased usually feeling sexually excited when
validated sensation with intercourse. All having sexual intercourse increased
sexual function patients had posterior by 18.4% after the surgery
questionnaire colpoperineoplasty/vaginoplasty to (preoperatively 58.3% versus 76.7%,
(PISQ-12). repair the vaginal calibre and p=0.032).
Surg Technol introitus to its prechildbirth anatomic  Women were less likely to report
Int. state. Outcomes were analyzed by negative emotional reactions after
2014:24:253- using validated PISQ-12 before and the surgery (preoperatively 31.7%
260 at least 6 months after surgery. versus 5.1%, p<0.001).
CALIFORNIA
Author‟s conclusion:
This study had shown improved
function using a validated
questionnaire in patients undergoing
vaginal rejuvenation/vaginoplasty for
laxity.
Length
Number of
of follow
applicab
characteristics
le)
4. Pardo JS, Pre and post intervention study II-2 n=53 Colpoperine - 6 months  Compared to the situation prior to
Solà VD, Ricci oplasty surgery, 35 women (66%)
PA et al. Objective: Mean age: 45 experienced a great improvement
Colpoperineopl To report the results in terms of years (range 30- in sexual life, 24% experienced
asty in women general acceptability and 66) significant improvement, 6%
with a satisfaction, and whether the experienced slight improvement,
sensation of a procedure enhanced the sensation Women with a and 2 patients (4%) had no
wide vagina. of vaginal tightness and sexual sensation of improvement at all
Acta Obstet gratification reported by the woman. wide vagina in  Fifty women (94%) said they were
Gynecol combination with able to reach orgasm and 51
Scand. Method: a decrease or women (96%) felt an adequate
2006;85(9):112 Between November 2003 and lack of ability to tightening of the vagina. Two
5-1127. October 2004, a total of 53 women reach orgasm. patients regretted having
25
with sexual dissatisfaction and a undergone surgery.

CHILE sensation of wide vagina were
selected for colpoperineoplasty at Author‟s conclusion:
Las Condes Clinic, Chile. All In a selected group of women with
patients had a site-specific anterior acquired sensation of a wide vagina,
and posterior repair. The colpoperineoplasty seems to improve
participants were requested to symptoms and enhance sexual
answer identical questionnaires gratification in a majority of the
before and 6 months after surgery women. A controlled trial with a longer
to assess the participants‟ follow-up is needed for a proper
satisfaction. evaluation.
Length
Number of
of follow
applicab
characteristics
le)
5. Ulubay M, Cross sectional study II-3 n=64 Perineoplast - 6 months  38 patients completed the survey.
Keskin U, y  Preoperative and postoperative
Fidan U et al. Objective: Mean age: 48 genital hiatus, perineal length, and
Safety, To investigate the safety, efficiency (range 26-68) total vaginal length were 4.62 and
efficiency, and and outcomes of perineoplasty in 3.18 (p<0.01), 3.06 and 4.04
outcomes of woman with the sensation of wide Patients had at (p<0.01), and 9.43 and 9.43
perineoplasty: vagina. least one (p=0.882), respectively.
treatment of the vaginal delivery,
sensation of a Method: requested Author‟s conclusion:
wide vagina. Between January 2012 and surgery for wide With low dyspareunia rates, low
Biomed Res September 2015, patient records of vagina complication rates, high patient
Int. women presented with sensation of sensation, satisfaction, and satisfactory
2016;2016:249 wide vagina and treated with underwent anatomical success, perineoplasty
26
5105. perineoplasty were reviewed. perineoplasty, can be considered successful for

Preoperative and postoperative and had regular treatment of the sensation of a wide
TURKEY genital hiatus length, perineal or irregular vagina.
length, and total vaginal length in sexual
patients treated with perineoplasty intercourse
were recorded. At least 6 months following the
after surgery, a telephone survey operation.
was used to determine
postoperative patient and male
partner satisfaction rates.
Length
Number of
of follow
applicab
characteristics
le)
6. Goodman Multicentre cross sectional study II-3 n=258  Labiaplast - 6-42  Enhancement of sexual function:
MP, Placik OJ, y months  64.7% (106/164) of women and
Benson RH et Objective: Vulvar work  Reduction 35.7% (60/168) of their partner
al. A large To investigate outcomes, in terms of group (LP of the for LP/RCH
multicenter patients overall and sexual and/or RCH): clitoral  86.6% (39/45) of women and
outcome study satisfaction, of female genital plastic 177 hood 82.2% (37/45) of their partner for
of female genital surgery (FGPS) procedures,  Perineopla VP/PP
plastic surgery. specifically labiaplasty (LP), Vaginal work sty  92.8% (26/28) of women and
J Sex Med. reduction of the clitoral hood (RCH), group: VP  Vaginoplas 82.2% (23/28) of their partner for
2010: 7(4 Pt perineoplasty (PP), vaginoplasty and/or PP: 47 ty combined procedures
1):1565-1577. (VP).
Combined group  Significant subjective enhancement
UNITED Method: (LP with VP/PP in sexual functioning for both
27
st st
STATES Between 1 January 2005 and 31 with or without women and their sexual partners
May 2008, 258 records of patient RCH): 34 was noted (p=0.0078), especially
undergoing FGPS were reviewed. in patients undergoing VP/PP
Twelve surgeon experienced in procedures.
FGPS from 10 centres were
recruited. Data were collected Author‟s conclusion:
retrospectively via questionnaires to From the results of this large study
analyze: pooling data from a diverse group of
1. Patient‟s and physician‟s experienced genital plastic surgeons,
perception of surgical rationale outcome in both general and sexual
2. Preoperative sexual function satisfaction appear excellent.
3. Overall patients satisfaction
4. Effect of patient‟s sexual
enjoyment,
5. Patient‟s perception of effect on
her partner‟s sexual enjoyment
6. Complication
Length
Number of
of follow
applicab
characteristics
le)
7. Gaviria JE, Cross sectional study II-3 n=103 Laser - 3 years  60 patients (58.3%) participated in
Korosec B, vaginal the telephone interview.
Fernandez J et Objective: Mean age:39 tightening  According to the patients‟ evaluation
al. Up to 3-year To evaluate the long term efficacy of years (range 20- (Er:YAG of the results, the average duration
follow-up of laser vaginal tightening (LVT). 74) laser, of effect after the therapy was 16
patients with IntimaLaser months, with significant improvement
vaginal Method: Participants ®) of stress urinary incontinence and
relaxation A total of 103 patients with vaginal were divided prolapse.
syndrome relaxation syndrome and treated into 4 groups:  The majority of results (30%)
participating in with a 2940nm Er:YAG laser persisted 18 to 24 months.
laser vaginal between June 2011 and May 2014  Group 1:
tightening. J were included in this study. The Patients with Author‟s conclusion:
Laser Heal treatment consisted of 1 to 4 different Two treatments are sufficient for
28
Acad. treatment session. All patients were stages of obtaining a long-lasting improvement
2016:2016(1):6- required to complete the PISQ-12 prolapse of vaginal relaxation syndrome, and a
11 questionnaire to assess the sexual (POP) and follow-up evaluation visit 8 months
prior to treatment and at follow up. Stress Urinary after the second treatment would be
VENEZUELA Telephone interviews were obtained Syndrome recommended, followed by a
asking patients to answer the LVT (SUI), n=5 maintenance session if needed.
questionnaire and self-assess the  Group 2:
efficacy of the IntimaLase® laser Patients with
vaginal tightening treatment, based POP without
on 6, 12, 18, 24 and 36-month SUI, n=11
follow ups.  Group 3:
Patients with
SUI without
POP, n=5
 Group 4:
Patients
without POP
and SUI, n=39
Length
Number of
of follow
applicab
characteristics
le)
8. Krychman M, Randomised controlled trial II-2 n=186 Radiofreque Sham 6 months  Of randomised subjects, 174
Rowan CG, ncy therapy treatment received RF therapy (active n=117,
Allan BB et al. Objective: mean age: 40.8 sham n=57)
Effect of single- To evaluate the efficacy and safety years old  No vaginal laxity was achieved at 6
treatment, of surface-cooled, monopolar months after treatment by 43.5% and
surface-cooled radiofrequency (RF) therapy for the Women with 19.6% (P = 0.002) in the active and
radiofrequency treatment of vaginal laxity in the vagina laxity, sham groups, respectively.
therapy on VIVEVE I trial. premenopausal  The minimally clinical important
vaginal laxity status, age at differences (MCID) analyzed at six
and female Method: least 18 years, months shown an improvement of at
sexual function: The VIVEVE I trial was a at least one full- least two points (on the seven-point
The VIVEVE I prospective, randomised, single- term vaginal Likert scale) in 57 subjects (52.8%)
Randomized blinded, and sham-controlled study delivery, and in the active group and 17 (30.4%) in
29
Controlled Trial. conducted at nine centres in normal genito- the sham group (p=0.006). MCID
J Sex Med. Canada, Spain, Italy and Japan. pelvic OR=2.63, 95% CI (1.31-5.27)
2017;14(2):215- Between January 2015 and examination  The adjusted mean changes on the
225. November 2015, women presenting results. FSFI total score were 4.16 and 2.36
with vaginal laxity were enrolled and for the active and sham groups,
UNITED randomised (2:1) to received RF Active treatment respectively (adjusted
2
STATES therapy (Active [90 J/cm ] vs Sham group, n=123 difference=1.80; 95% CI=0.17-3.43)
2
[1 J/cm ], respectively) delivered to  The MCID for the FSFI total score
the vaginal tissue. The primary Sham treatment shown an improvement of at least
efficacy outcome on vaginal laxity group, n=63 4.8 points in 46 subjects (42.6%) in
was assessed using the Vaginal the active group and 14 (30.4%) in
Laxity Questionnaire (VLQ). the sham group (p=0.036).
Secondary efficacy assessment of MCID OR=2.46, 95% CI (1.06-5.72)
sexual function and distress were
evaluated using the Female Sexual Author‟s conclusion:
Function Index (FSFI) and the A single treatment of RF therapy was
revised Female Sexual Distress found to be safe and associated with
Scale (FSDS-R). both improved vaginal laxity and
improved sexual function.
Length
Number of
of follow
applicab
characteristics
le)
9. Sekiguchi Y, Pre and post intervention study II-2 n=30 Radiofreque - 12  Sexual function improved
Utsugisawa Y, ncy therapy months significantly throughout 6 months.
Azekosi Y et al. Objective: mean age: 42.9  Participants reported decreased
Laxity of the To report the long-term years (range 30- vaginal laxity within the first month
vaginal introitus effectiveness of a single nonsurgical 52 years) after the procedure (p<0.001);
after childbirth: procedure with RF energy for laxity responses peaked, and
nonsurgical at the vaginal introitus. Women with effectiveness was sustained through
outpatient vaginal laxity, 12 months (p<0.001).
procedure for Method: premenopausal,  Mean FSFI total score was 22.4±6.7
vaginal tissue Between January and December at least one full before treatment and then improved
restoration and 2011, 30 Japanese women with term vaginal to mean 26.0±5.8 at month 6
improved sexual vaginal introital laxity were enrolled delivery (p=0.002), inclusive of improved
satisfaction in this study. A single RF treatment scores in five of six FSFI domains
30
2
using low- (90 J/cm ) was performed on each except desire (p<0.001 –<0.01).
energy participants. All participants were  In the 22 of 30 participants remaining
radiofrequency required to complete questionnaires evaluable at 12 months, the mean
thermal therapy. before the treatment and at months was 26.0±5.2 (p=0.08).
J Womens 1,3,6 and 12 (post-treatment). The
Health 12-month outcome assessments Author‟s conclusion:
(Larchmt). included the linguistic validated A single RF procedure for vaginal
2013;22(9):775- Japanese versions of the FSFI, introital laxity achieved significant and
781. FSDS-R, VLQ and Sexual sustainable 12-month effectiveness
Satisfaction Questionnaire (SSQ). with respect to improved integrity at
JAPAN the vaginal introitus and improved
sexual satisfaction.
Length
Number of
of follow
applicab
characteristics
le)
10. Vicariotto F, Pre and post intervention study II-2 n=25 Dynamic - 2 months Vaginal laxity arm
Raichi M. quadripolar  Eleven of the enrolled women
Technological Objective: Vaginal laxity radiofrequen completed the five planned DQRF
evolution in the To investigate the safety and arm cy (DQRF) treatment sessions.
radiofrequency efficacy of a new low-energy n=12  There was a significant improvement
treatment of dynamic quadripolar radiofrequency Mean age: in VLQ mean scores (p<0.005) and
vaginal laxity (DQRF) device in women with 41.7±5.5 total PISQ-12 score (34.5±6.8 vs
and menopausal vaginal laxity and vulvo-vaginal Women with 38.5±6.1, p<0.005) at the first
vulvo-vaginal atrophy (VVA) and genitourinary subjective assessment visit.
atrophy and syndrome of menopause (GSM). perception of
other vaginal laxity VVA/GSM arm
genitourinary Method:  12 women completed the four DQRF
symptoms: first Between January and July 2015, 12 VVA/GSM arm sessions planned in the VVA/GSM
31
experiences with women with vagina laxity and 13 n=13 arm of the study.
a novel dynamic women with VVA/GSM were mean age:  The mean VAS score for overall
quadripolar enrolled in the vaginal laxity arm 60.4±6.5 satisfaction with sexual life improved
device. Minerva and VVA/GSM arm of the study, Postmenopausal from 4.3±1.4 at baseline up to
Ginecol. respectively. Women in vaginal women with 7.0±2.0 after first assessment visit
2016;68(3):225- laxity arm underwent five 20- subjective and 7.7±2.4 at the last follow-up visit.
236. minutes DQRF thermal treatment perception of
sessions every 14±1 days. A vulvo- vaginal dryness Author‟s conclusion:
ITALY vaginal laxity questionnaire (VVLQ, and other The DQRF treatment was well
certified Italian translation) and short VVA/GSM- tolerated, with no pain during the
form of the Pelvic Organ related procedure and no untoward effect
Prolapse/Urinary Incontinence syndrome. reported over the 2-month follow-up
Sexual Questionnaire (PISQ-12, periods in both arms of the study.
Italian certified translation) were Improvements in self-reported VVLQ
used to assess urinary and PISQ-12 scores (vaginal laxity
incontinence, sexual gratification arm) and VAS self-evaluation of
and the contribution of any VVA/GSM symptoms and overall
concomitant pelvic organ prolapse. satisfaction with sexual life
Women in VVA/GSM arm (VVA/GSM arm of the study) were
underwent four 10-minutes DQRF rapid and persistent.
sessions every 10±1 days.
Specifically designed visual
analogue scales (VAS) for
VVA/GSM symptoms and overall
satisfaction with sexual life were
used.
Three office follow-up visits were
planned: immediately before the last
procedure (after 56±4 days in
women with vaginal laxity and after
30±3 in women with VVA/GSM) and
after 30±1 and 60±1 days following
this first follow-up assessment.
32
Length
Number of
of follow
applicab
characteristics
le)
11. Lalji S, Pre and post intervention study II-2 n=27 Monopolar - 1 month  Improvement in treated conditions
Lozanova P. radiofrequen was reported immediately after the
Evaluation of the Objective: Mean age: 44.8 cy last treatment session and was even
safety and To investigate the efficacy and years (range 28- more significant after the 1-month
efficacy of a safety of a monopolar 66) follow-up visit.
monopolar radiofrequency device for  At 1-month follow up, 96.3% (26/27)
nonablative transvaginal treatment of stress Patients with subjects with SUI reported
radiofrequency urinary incontinence (SUI) and mild to moderate improvement of at least one level,
device for the vulvo-vaginal laxity. SUI and vaginal with 15 subjects (55.6%) showing
improvement of laxity improvement of two or more levels
vulvo-vaginal Method: when comparing the baseline to the
laxity and A total of 27 women who follow-up visit.
urinary experienced mild to moderate SUI  The VVLQ score increased from
33
incontinence. J and vaginal laxity were enrolled in 2.19 ± 1.08 to 5.74 ± 0.76 one month
Cosmet this study. All subjects were treated after treatment
Dermatol. with monopolar radiofrequency
2017;00:1–5. device. The treatment course Author‟s conclusion:
consisted of three once-a-week The study confirmed the monopolar
UNITED sessions. Improvement in the SUI radiofrequency method as an
STATES condition was evaluated by applying effective and safe treatment of SUI
the International Consultation on and vulvo-vaginal laxity. The
Incontinence Questionnaire - treatments were well tolerated by all
Urinary Incontinence Short Form subjects with no adverse effects.
(ICIQ-UI SF). Data were collected at
the baseline, after the last treatment
and at 1-month follow-up visit.
Vaginal laxity was assessed by
subjective vulvo-vaginal laxity
questionnaire (VVLQ). Data were
collected before the 1st treatment
and during the 1-month follow-up
visit. Patient‟s satisfaction was
recorded using a satisfaction
questionnaire. Data were collected
after the last treatment and at the 1-
month follow-up visit.
Evidence Table : Safety
Question : Is surgical and non-surgical method safe for vaginal tightening?
Length
Number of
of follow
applicab
characteristic
le)
1. Abedi P, Pre and post intervention study II-2 n=79 Colpoperine - 6 months  Dyspareunia increased and
Jamali S, oplasty lubrication decreased significantly
Tadayon M et Objective: Mean age: (p<0.001).
al. To evaluate the effect of selective 34.02 ± 5.3  Six months after surgery,
Effectiveness vaginal tightening on sexual functions years 37(46.8%) women had
of selective in women of reproductive age with dyspareunia most of the time, 14
vaginal vaginal laxity in Iran. Married woman (17.7%) seldom, 26 (32.9%)
tightening on with vaginal sometimes, one (1.3%) did not
sexual function Method: laxity, literate have any pain and one (1.3%)
among Between May 2011 and March 2012, and aged 15-45 always had dyspareunia.
reproductive 86 women with vaginal laxity in years.
aged women Jahrome, Iran were enrolled in this
in Iran with study. All participants were requested
34
vaginal laxity: to complete a sociodemographic

a quasi- questionnaire and a Female Sexual
experimental Function Index (FSFI) preoperatively,
study. J Obstet and FSFI questionnaire 6 months
Gynaecol Res. after vaginal tightening. The FSFI
2014;40(2):52 contained 19 questions including two
6-531. questions in the libido domain, four
questions in the sexual arousal area,
IRAN four questions in the lubrication area,
and three questions each for orgasm,
sexual satisfaction and pain. A five-
point Likert scale was used for
scoring. Participants were followed up
at 1 week, 1 month, 2 months, 3
months and 6 months after surgery.
Length
Number of
of follow
applicab
characteristic
le)
2. Jamali S, Prospective cohort study II-2 n=86 Colpoperino - 18  Dyspareunia and lubrication
Abedi P, plasty months improved significantly (p<0.001).
Rasekh A et Objective: Mean age:
al. The long To evaluate the long term effect of 34.02 ± 5.3
term effect of colpoperineoplasty on sexual function years
elective among women who complained of
colpoperineopl vaginal laxity in Iran. Married woman
asty on sexual with vaginal
function in the Method: laxity, literate
reproductive This was a continue study from Abedi and aged 15-45
aged women et al. All patients were required to years.
in Iran. Int Sch recomplete the questionnaire 18
Res Notices. months after surgery.
35
2014;4:
912786.
IRAN
Length
Number of
of follow
applicab
characteristic
le)
3. Moore Pre and post intervention study II-2 n=78 Posterior - 6 months  Pain with intercourse subscores
RD, Miklos JR, colpoperineo were found to be no different from
Chinthakanan Objective: Mean age: 43.6 plasty/vagino preoperatively to postoperatively.
O. Evaluation To evaluate the sexual function (range 25 to 62) plasty
of sexual outcomes by validated Pelvic Organ
function Prolapse/Urinary Incontinence Sexual Women with
outcomes in Questionnaire-12 (PISQ-12) chief complaint
women compared between preoperative and of vaginal
undergoing postoperative values in a group of laxity/looseness
vaginal women presenting for vaginal causing sexual
rejuvenation/v rejuvenation surgery. dysfunction and
aginoplasty desiring vaginal
procedures for Method: rejuvenation
36
symptoms of Sexual function outcomes were surgery, age

vaginal analyzed in a group of women more than 18,
laxity/decrease presenting for vaginal and clinically
d vaginal rejuvenation/vaginoplasty procedures confirm vaginal
sensation for a chief complaint of vaginal laxity laxity on exam.
utilizing and decreased sensation with
validated intercourse. All patients had posterior
sexual function colpoperineoplasty/vaginoplasty to
questionnaire repair the vaginal calibre and introitus
(PISQ-12). to its prechildbirth anatomic state.
Surg Technol Outcomes were analyzed by using
Int. validated PISQ-12 before and at least
2014:24:253- 6 months after surgery.
260
CALIFORNIA
Number of Length
patients and of follow
Bibliographic Study Outcome measures/ General
LE patient Intervention Comparison up (if
citation Type / Methodology Effect size comments
characteristic applicab
s le)
4. Pardo JS, Pre and post intervention study II-2 n=53 Colpoperine - 6 months Two women (4%) experienced
Solà VD, Ricci oplasty minimal surgical wound dehiscence
PA et al. Objective: Mean age: 45 (affecting the vagina and the
Colpoperineop To report the results in terms of years (range perineum) that resolved
lasty in women general acceptability and satisfaction, 30-66) spontaneously.
with a and whether the procedure enhanced
sensation of a the sensation of vaginal tightness and Women with a
wide vagina. sexual gratification reported by the sensation of
Acta Obstet woman. wide vagina in
Gynecol combination
Scand. Method: with a
2006;85(9):11 Between November 2003 and decrease or
25-1127. October 2004, a total of 53 women lack of ability
37
with sexual dissatisfaction and a to reach

CHILE sensation of wide vagina were orgasm.
selected for colpoperineoplasty at Las
Condes Clinic, Chile. All patients had
a site-specific anterior and posterior
repair. The participants were
requested to answer identical
questionnaires before and 6 months
after surgery to assess the
participants‟ satisfaction.
Length
Number of
of follow
applicab
characteristic
le)
5. Ulubay Cross sectional study II-3 n=64 Perineoplast - 6 months  Ten percent (4/38) of patients
M, Keskin U, y experienced dyspareunia during
Fidan U et al. Objective: Mean age: 48 sexual intercourse at the introitus
Safety, To investigate the safety, efficiency and (range 26-68) of the vagina.
efficiency, and outcomes of perineoplasty in woman
outcomes of with the sensation of wide vagina. Patients had at
perineoplasty: least one
treatment of Method: vaginal
the sensation Between January 2012 and September delivery,
of a wide 2015, patient records of women requested
vagina. presented with sensation of wide surgery for
Biomed Res vagina and treated with perineoplasty wide vagina
Int. were reviewed. Preoperative and sensation,
38
2016;2016:249 postoperative genital hiatus length, underwent

5105. perineal length, and total vaginal length perineoplasty,
in patients treated with perineoplasty and had
TURKEY were recorded. At least 6 months after regular or
surgery, a telephone survey was used irregular
to determine postoperative patient and sexual
male partner satisfaction rates. intercourse
following the
operation.
Length
Number of
of follow
applicab
characteristic
le)
6. Goodman Multicentre cross sectional study II-3 n=258  Labiaplast - 6-42  Complication were reported in:
MP, Placik y months  8.5% (15/177) of patients who
OJ, Benson Objective: Vulvar work  Reduction had LP/RCH
RH et al. A To investigate outcomes, in terms of group (LP of the  16.6% (8/47) of patients who had
large patients overall and sexual satisfaction, and/or RCH): clitoral VP/PP
multicenter of female genital plastic surgery 177 hood  18.2% (6/33) of patients who had
outcome study (FGPS) procedures, specifically  Perineopla combined procedures
of female labiaplasty (LP), reduction of the clitoral Vaginal work sty  The complication percentages from
genital plastic hood (RCH), perineoplasty (PP), group: VP  Vaginoplas physician‟s perspective were:
surgery. J Sex vaginoplasty (VP). and/or PP: 47 ty  6% (11/177) of patients who had
Med. 2010: LP/RCH
7(4 Pt 1):1565- Method: Combined  25% (11/47) of patients who had
st st
1577. Between 1 January 2005 and 31 May group (LP with VP/PP
39
2008, 258 records of patient VP/PP with or  18% (6/34) of patients who had
UNITED undergoing FGPS were reviewed. without RCH): combined procedures
STATES Twelve surgeon experienced in FGPS 34
from 10 centres were recruited. Data  Rectal perforation was reported in
were collected retrospectively via one patient who had VP/PP
questionnaires. procedure. Healing time longer
than expected (2.7%), dyspareunia
(2.7%) and unexpected
postoperative bleeding (1.9%)
were also reported. Five patients
(1.9%) experienced excessive pain
after surgery, temporarily
interfering with sexual function.
Length
Number of
of follow
applicab
characteristic
le)
7. Gaviria JE, Cross sectional study II-3 n=103 Laser - 3 years  Adverse effects were limited to mild
Korosec B, vaginal and transient edema and a tolerable
Fernandez J et Objective: Mean age:39 tightening heating sensation in a few cases.
al. Up to 3- To evaluate the long term efficacy of years (range (Er:YAG
year follow-up laser vaginal tightening (LVT). 20-74) laser,
of patients with IntimaLaser
vaginal Method: Participants ®)
relaxation A total of 103 patients with vaginal were divided
syndrome relaxation syndrome and treated with a into 4 groups:
participating in 2940nm Er:YAG laser between June
laser vaginal 2011 and May 2014 were included in  Group 1:
tightening. J this study. The treatment consisted of 1 Patients with
Laser Heal to 4 treatment session. All patients different
40
Acad. were required to complete the PISQ-12 stages of

2016:2016(1): questionnaire to assess the sexual prior prolapse
6-11 to treatment and at follow up. (POP) and
Telephone interviews were obtained Stress
VENEZUELA asking patients to answer the LVT Urinary
questionnaire and self-assess the Syndrome
efficacy of the IntimaLase® laser (SUI), n=5
vaginal tightening treatment, based on  Group 2:
6, 12, 18, 24 and 36-month follow ups. Patients with
POP without
SUI, n=11
 Group 3:
Patients with
SUI without
POP, n=5
 Group 4:
Patients
without POP
and SUI,
n=39
Length
Number of
of follow
applicab
characteristic
le)
8. Krychman Randomised controlled trial II-2 n=186 Radiofreque Sham 6 months  Treatment-emergent adverse events
M, Rowan CG, ncy therapy treatment (TEAE) were reported by
Allan BB et al. Objective: mean age: 11.1%(13/117) and 12.3%(7/57) of
Effect of To evaluate the efficacy and safety of 40.8 years old subjects in the active and sham
single- surface-cooled, monopolar groups, respectively.
treatment, radiofrequency (RF) therapy for the Women with  Most frequently reported related
surface-cooled treatment of vaginal laxity in the vagina laxity, TEAE was vaginal discharged, which
radiofrequency VIVEVE I trial. premenopausa occurred in 2.6% (3/117) and 3.5%
therapy on l status, age at (2/57) subjects in the active and
vaginal laxity Method: least 18 years, sham groups, respectively.
and female The VIVEVE I trial was a prospective, at least one
sexual randomised, single-blinded, and sham- full-term
function: The controlled study conducted at nine vaginal
41
VIVEVE I centres in Canada, Spain, Italy and delivery, and

Randomized Japan. Between January 2015 and normal genito-
Controlled November 2015, women presenting pelvic
Trial. J Sex with vaginal laxity were enrolled and examination
Med. randomised (2:1) to received RF results.
2
2017;14(2):21 therapy (Active [90 J/cm ] vs Sham [1
2
5-225. J/cm ], respectively) delivered to the Active
vaginal tissue. treatment
UNITED group, n=123
STATES
Sham
treatment
group, n=63
Length
Number of
of follow
applicab
characteristic
le)
9. Sekiguchi Pre and post intervention study II-2 n=30 Radiofreque - 12  Seven (23%) participants reported
Y, Utsugisawa ncy therapy months sporadic discomfort/pain with 1(3%)
Y, Azekosi Y Objective: mean age: reported excessive but sporadic
et al. Laxity of To report the long-term effectiveness of 42.9 years pain.
the vaginal a single nonsurgical procedure with RF (range 30-52  One case each of mild vaginal
introitus after energy for laxity at the vaginal introitus. years) leukorrhea and mild lower abdominal
childbirth: pain were reported.
nonsurgical Method: Women with
outpatient Between January and December 2011, vaginal laxity,
procedure for 30 Japanese women with vaginal premenopausa
vaginal tissue introital laxity were enrolled in this l, at least one
42
2
restoration and study. A single RF treatment (90 J/cm ) full term
improved was performed on each participants. All vaginal
sexual participants were required to complete delivery
satisfaction questionnaires before the treatment
using low- and at months 1,3,6 and 12 (post-
energy treatment). The 12-month outcome
radiofrequency assessments included FSFI, FSDS-R
thermal and VLQ.
therapy. J
Womens
Health
(Larchmt).
2013;22(9):77
5-781.
JAPAN
Evidence Table : Social
Question : Is surgical and non-surgical method accepted for vaginal tightening?
Number of Length of
patients and follow up
Bibliographic Study Outcome measures/ General
LE patient Intervention Comparison (if
citation Type / Methodology Effect size comment
characteristic applicabl
s e)
1. Ulubay Cross sectional study II-3 n=64 Perineoplast - 6 months  At the 6 month follow-up, patient's
M, Keskin U, y reported satisfaction rate was
Fidan U et al. Objective: Mean age: 48 87.9%±6.8, while reported
Safety, To investigate the safety, efficiency and (range 26-68) partner's satisfaction rate was
efficiency, and outcomes of perineoplasty in woman 92.6%±7.6.
outcomes of with the sensation of wide vagina. Patients had at  The number of patients who would
perineoplasty: least one recommend the procedure to
treatment of Method: vaginal friends was also high (87.9%±6.8).
the sensation Between January 2012 and September delivery,
of a wide 2015, patient records of women requested
vagina. presented with sensation of wide vagina surgery for
Biomed Res and treated with perineoplasty were wide vagina
43
Int. reviewed. Preoperative and sensation,

2016;2016:24 postoperative genital hiatus length, underwent
95105. perineal length, and total vaginal length perineoplasty,
in patients treated with perineoplasty and had
TURKEY were recorded. At least 6 months after regular or
surgery, a telephone survey was used to irregular
determine postoperative patient and sexual
male partner satisfaction rates. intercourse
following the
operation.
Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up Effect size comment
patient (if
e)
2. Goodman Multicentre cross sectional study II-3 n=258  Labiaplast - 6-42  The reasons for surgery from
MP, Placik y months patient‟s and physician‟s
OJ, Benson Objective: Vulvar work  Reduction perspective were broken down
RH et al. A To investigate outcomes, in terms of group (LP of the into five categories which were
large patients overall and sexual satisfaction, and/or RCH): clitoral functional, cosmetic appearance,
multicenter of female FGPS procedures, specifically 177 hood the perception of being abnormal,
outcome labiaplasty (LP), reduction of the clitoral  Perineopla vaginal relaxation and sexual
study of hood (RCH), perineoplasty (PP), Vaginal work sty pleasure, and partner‟s sexual
female genital vaginoplasty (VP). group: VP  Vaginoplas pleasure.
plastic and/or PP: 47 ty
surgery. J Method:  LP/RCH : 75.7% (134/177) with
st st
Sex Med. Between 1 January 2005 and 31 May Combined functional and cosmetic
44
2010: 7(4 Pt 2008, 258 records of patient undergoing group (LP with appearance issues
1):1565-1577. FGPS were reviewed. Twelve surgeon VP/PP with or  VP/PP: 58.3% (27/47)with
experienced in FGPS from 10 centres without RCH): sexual issue
UNITED were recruited. Data were collected 34  Combined: 56.8% (19/34) with
STATES retrospectively via questionnaires to sexual issues
analyze:  The physician‟s perspective
1. Patient‟s and physician‟s perception regarding the reasons their
of surgical rationale individual patients underwent
2. Preoperative sexual function surgery parallel that of their
3. Overall patients satisfaction patients in all of the groups.
4. Effect of patient‟s sexual enjoyment,
5. Patient‟s perception of effect on her  Overall satisfaction reported by
partner‟s sexual enjoyment patients:
6. Complication  97.2% (172/177) for LP/RCH
procedures
 83.0% (39/47) for VP/PP
procedures
 91.2% (31/34) for combined
procedures
 The physician's estimation parallel
that of their patients, reporting
positive results in 97%, 92% and

patient (if
e)
94%, respectively.
From the results of this large study
pooling data from a diverse group of
experienced genital plastic surgeons,
outcome in both general and sexual
satisfaction appear excellent.
45

patient (if
e)
3. Gaviria JE, Cross sectional study II-3 n=103 Laser - 3 years  58.0% (35/60) of participants highly
Korosec B, vaginal satisfied with the results of the
Fernandez J Objective: Mean age:39 tightening treatment. 11.6% (7/60) were poorly
et al. Up to 3- To evaluate the long term efficacy of years (range (Er:YAG satisfied with limited or no treatment
year follow-up laser vaginal tightening (LVT). 20-74) laser, outcomes.
of patients IntimaLaser  83.3% of participants would be
with vaginal Method: Participants ®) willing to repeat the therapy.
relaxation A total of 103 patients with vaginal were divided  90% (54/60) would also recommend
syndrome relaxation syndrome and treated with a into 4 groups: the treatment.
participating 2940nm Er:YAG laser between June
in laser 2011 and May 2014 were included in  Group 1: Author‟s conclusion:
vaginal this study. The treatment consisted of 1 Patients with Two treatments are sufficient for
tightening. J to 4 treatment session. All patients were different
46
obtaining a long-lasting improvement

Laser Heal required to complete the PISQ-12 stages of of vaginal relaxation syndrome, and a
Acad. questionnaire to assess the sexual prior prolapse follow-up evaluation visit 8 months
2016:2016(1): to treatment and at follow up. Telephone (POP) and after the second treatment would be
6-11 interviews were obtained asking patients Stress recommended, followed by a
to answer the LVT questionnaire and Urinary maintenance session if needed.
VENEZUELA self-assess the efficacy of the Syndrome
IntimaLase® laser vaginal tightening (SUI), n=5
treatment, based on 6, 12, 18, 24 and  Group 2:
36-month follow ups. Patients with
POP without
SUI, n=11
 Group 3:
Patients with
SUI without
POP, n=5
 Group 4:
Patients
without POP
and SUI,
n=39

patient (if
e)
4. Vieira- Cross sectional study II-3 n= 664 VVAPs - -  Most participants considered that
Baptista P, there is never or there rarely is a
Lima-Silva J, Objective: Medical medical reason to perform: vulvar
Fonseca- To assess the medical doctors and doctors and whitening (85.9% [502/584]);
Moutinho J et medical students' opinion regarding the medical hymenoplasty (72.0% [437/607]);
al. Survey on evidence and ethical background of the students aged mons pubis liposuction (71.6%
Aesthetic performance of vulvovaginal aesthetic 18-69 years. [426/595]); "G-spot" augmentation
Vulvovaginal procedures (VVAPs). (71.0% [409/576]); labia majora
Procedures: Specialist: augmentation (66.3% [390/588]);
What do Method: 37.0% labia minora augmentation (58.3%
Portuguese Between September 2015 and February (246/664) [326/559]); or laser vaginal
Doctors and 2016, an online survey was sent to the tightening (52.3% [313/599]).
Medical target population via email, and posted Students:  Gynecologists and specialists were
47
Students in the websites of medical societies and 34.2% more likely to consider that there are
Think? Rev in specific social network groups (227/664) no medical reasons to perform
Bras Ginecol (exclusively for doctors/medical VVAPs; the opposite was true for
Obstet. students). Residents: plastic surgeons and
2017;39(8):41 28.8% students/residents.
5-423. (191/664)  Plastic surgeons and
students/residents were less likely to
raise ethical objections, while the
opposite was true for gynecologists
and specialists.
PORTUGAL  Most considered that VVAPs could
contribute to an improvement in self-
esteem (92.3% [613/664]); sexual
function (78.5% [521/664]); vaginal
atrophy (69.9% [464/664]); quality of
life (66.3% [440/664]); and sexual
pain (61.4% [408/664]).
 The majority agreed, at least
partially, that: all women should be
evaluated by a
psychiatrist/sexologist prior to
surgery (552/664 [83.1%]); if

patient (if
e)
performed, these surgeries should
take place in public hospitals
(381/664 [57.3%]); advertising them
should be forbidden (339/664
[51.0%]).
While medical doctors and students
acknowledge the lack of evidence and
scientific support for the performance
of VVAPs, most do not raise ethical
objections about them, especially if
they are students or plastic surgeons,
or if they have had or have considered
48
having plastic surgery.

Bibliographic Study LE Number of Intervention Comparison Length Outcome measures/ General

citation Type / Methodology patients and of follow Effect size comments
patient up (if
characteristic applicab
s le)
5. Krychman Randomised controlled trial II-2 n=186 Radiofrequenc Sham 6 months  Results on the sexual distress scale
M, Rowan CG, y therapy treatment (FSDS-R total score) showed a
Allan BB et al. Objective: mean age: borderline significant findings of less
Effect of To evaluate the efficacy and safety of 40.8 years old distress for the active group
single- surface-cooled, monopolar compared with the sham group
treatment, radiofrequency (RF) therapy for the Women with (p=0.056)
surface-cooled treatment of vaginal laxity in the vagina laxity,  The MCID for the FSDS-R total
radiofrequency VIVEVE I trial. premenopausa score shown an improvement of at
therapy on l status, age at least 5.9 points in 58 subjects
vaginal laxity Method: least 18 years, (54.2%) in the active group and 19
and female The VIVEVE I trial was a prospective, at least one (33.9%) in the sham group.
sexual randomised, single-blinded, and full-term MCID OR=2.33 with 95% CI (1.07-
function: The sham-controlled study conducted at vaginal 5.07).
49
VIVEVE I nine centres in Canada, Spain, Italy delivery, and

Randomized and Japan. Between January 2015 normal genito-
Controlled and November 2015, women pelvic
Trial. J Sex presenting with vaginal laxity were examination
Med. enrolled and randomised (2:1) to results.
2017;14(2):21 received RF therapy (Active [90
2 2
5-225. J/cm ] vs Sham [1 J/cm ], Active
respectively) delivered to the vaginal treatment
UNITED tissue. group, n=123
STATES
Sham
treatment
group, n=63

citation Type / Methodology patients and follow up Effect size comments
patient (if
characteristics applicabl
e)
6. Sekiguchi Pre and post intervention study II-2 n=30 Radiofrequency - 12 months  Significant improvement in sexual
Y, Utsugisawa therapy satisfation as reported on the SSQ
Y, Azekosi Y Objective: mean age: 42.9 were perceived at each follow up
et al. Laxity of To report the long-term years (range assessment in 13 of the 17 (76.5%)
the vaginal effectiveness of a single 30-52 years) subjects who expressed decreased
introitus after nonsurgical procedure with RF satisfation at study entry. The
childbirth: energy for laxity at the vaginal Women with pretreatment mean score of
nonsurgical introitus. vaginal laxity, 1.29±0.17 improved to 2.71±0.66 at
outpatient premenopausal, month 6 (p<0.001).
procedure for Method: at least one full  Distress related to sexual activity
vaginal tissue Between January and December term vaginal decreased significantly; baseline
restoration and 2011, 30 Japanese women with delivery FSDS-R mean score of 15.8±11.7
improved vaginal introital laxity were enrolled improved to 9.8±8.0 at one month
50
sexual in this study. A single RF treatment and was sustained throughout 12

2
satisfaction (90 J/cm ) was performed on each months (p<0.001–0.002).
using low- participants. All participants were
energy required to complete
radiofrequency questionnaires before the
thermal treatment and at months 1,3,6 and
therapy. J 12 (post-treatment). The 12-month
Womens outcome assessments included
Health FSFI, FSDS-R, VLQ and SSQ
(Larchmt).
2013;22(9):77
5-781.
JAPAN

citation Type / Methodology patients and follow up Effect size comments
patient (if
characteristics applicabl
e)
7. Lalji S, Pre and post intervention study II-2 n=27 Monopolar - 1 month During the follow-up visit, 89% of the
Lozanova P. radiofrequency patients “agreed” or “strongly
Evaluation of Objective: Mean age: 44.8 agreed” that their SUI condition
the safety and To investigate the efficacy and years (range improved, and 93% of the patients
efficacy of a safety of a monopolar 28-66) “agreed” or “strongly agreed” that
monopolar radiofrequency device for their gratification during intercourse
nonablative transvaginal treatment SUI and Patients with improved.
radiofrequency vulvo-vaginal laxity. mild to
device for the moderate SUI Author‟s conclusion:
improvement Method: and vaginal The study confirmed the monopolar
of vulvo- A total of 27 women who laxity radiofrequency method as an
vaginal laxity experienced mild to moderate SUI effective and safe treatment of SUI
and urinary and vaginal laxity were enrolled in and vulvo-vaginal laxity. The
51
incontinence. J this study. All subjects were treated treatments were well tolerated by all
Cosmet with monopolar radiofrequency subjects with no adverse effects.
Dermatol. device. The treatment course
2017;00:1–5. consisted of three once-a-week
sessions. Improvement in the SUI
UNITED condition was evaluated by
STATES applying the International
Consultation on Incontinence
Questionnaire - Urinary
Incontinence Short Form (ICIQ-UI
SF). Data were collected at the
baseline, after the last treatment
and at 1-month follow-up visit.
Vaginal laxity was assessed by
subjective VVLQ. Data were
collected before the 1st treatment
and during the 1-month follow-up
visit. Patient‟s satisfaction was
recorded using a satisfaction
questionnaire. Data were collected
after the last treatment and at the
1-month follow-up visit.
52

TR-Surgical and Non Surgical Method For Vaginal Tightening

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TR-Surgical and Non Surgical Method For Vaginal Tightening

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2017

SURGICAL AND NON-SURGICAL (INSTRUMENTAL)

HEALTH TECHNOLOGY ASSESSMENT SECTION (MaHTAS)

Please contact: htamalaysia@moh.gov.my, if you would like further

Health Technology Assessment Section (MaHTAS),

Tel: 603 88831246

Fax: 603 8883 1230

Available at the following website: http://www.moh.gov.my

Dr Shah Jumaat Mohd. Yussof

Dr Ravichandran A/L R. Jeganathan

Pregnancies, childbirth, aging, genetics, pelvic trauma and strenuous activity in

Vaginal laxity is a symptom of pelvic floor dysfunction generally caused by

Female Genital Cosmetic Surgery (FGCS) refers to a non-medically indicated

In a Global Aesthetic Survey 2016 conducted by International Society of

Hence, this technology review was requested by Medical Practise Division,

Vaginal laxity is a symptom of pelvic floor dysfunction generally caused by

Female Genital Cosmetic Surgery (FGCS) refers to non-medically indicated

Globally, there has been a great demand in vaginal rejuvenation. In a Global

Hence, this technology review was requested by Medical Practise Division,

Table 1: Energy-based devices for vaginal rejuvenation

Energy-based device Type Description

Figure 2: Radiofrequency-based devices

The inclusion and exclusion criteria were:

Population Woman with vaginal laxity, vaginal relaxation syndrome

Study Studies conducted in animals, narrative reviews, case

Relevant articles were critically appraised using Critical Appraisal Skills

4.3. Risk of bias

+ Indicates YES (low risk of bias)

5. RESULTS AND DISCUSSION

Number of records after duplicates removed (n=181)

Number of records Number of records

Number of full-text Number of full-text

Number of full-text articles

Figure 3: Flow chart of study selection

5.1.1. Risk of bias

Risk of bias assessment in the included studies are summarised according to

Free of other bias

Figure 4a: Assessment of risk of bias of RCT (Cochrane)

Figure 4b: Assessment of risk of bias of cohort (CASP)

Question or objective clearly stated?

Figure 4c: Assessment of risk of bias of pre-post studies with no

Four studies reported the effectiveness of non-surgical method of vaginal

5.2.1. Surgical method

5.2.1.1. Open surgery

Ulubay et al. (2016) conducted a cross sectional study to investigate the

Goodman et al. (2010) conducted a multicentre cross sectional study to

5.2.1.2. Laser surgery

Table 3: Changes in SUI and vulvo-vaginal laxity

Two studies reported the safety of non-surgical method of vaginal tightening,

5.3.1. Surgical method

5.3.1.1. Open surgery

Ulubay et al. (2016) investigate the safety of PP in 64 women with sensation of

Goodman et al. (2010) conducted a multicentre cross sectional study in 258

5.3.1.2. Laser surgery

5.3.2. Non-surgical method

5.4. PSYCHOLOGICAL / SOCIAL / ETHICAL

5.4.1. Surgical method

5.4.1.1. Open surgery

Goodman et al. (2010) conducted a multicentres cross sectional study in 258

5.4.1.2. Laser surgery

5.4.2. Non-surgical method

Sekiguchi et al. (2013) reported the changes in psychological distress

In Malaysia, the appropriateness or legality of vaginal tightening according to