PAIN

REVIEW

Outcome of Medical and Psychosexual Interventions for Vaginismus:

A Systematic Review and Meta-Analysis
Elisa Maseroli,1 Irene Scavello,1 Giulia Rastrelli,1 Erika Limoncin,2 Sarah Cipriani,1 Giovanni Corona,3
Massimiliano Fambrini,4 Angela Magini,1 Emmanuele A. Jannini,2 Mario Maggi,1,5 and Linda Vignozzi, MD, PhD1,5

ABSTRACT

Introduction: Although vaginismus is a condition with a great impact on psychosexual well-being, the evidence
on the efficacy of interventions is lacking.
Aim: To review all information on vaginismus treatment, including data from randomized clinical trials (RCTs)
and observational studies.
Methods: A systematic search was conducted of MEDLINE, EMBASE, PsycINFO, and ClinicalTrials.gov. 2
Independent meta-analyses of RCTs and observational studies were performed. For RCTs, only those having no
treatment as the comparator were considered eligible.
Main Outcome Measure: The primary outcome was the success rate (number of successes/total sample) in the
completion of sexual intercourse.
Results: 43 Observational studies (n ¼ 1,660) and 3 RCTs (n ¼ 264) were included in the final analyses,
respectively. In the meta-analysis of RCTs, the use of psychological interventions showed a trend toward a
significantly better result vs waiting list control (OR 10.27 [95% CI 0.79e133.5], P ¼ .075). The combination
of the results obtained from the observational studies showed that treating vaginismus is associated with the
completion of sexual penetrative intercourse in 79% of cases, independently of the therapy used (success rate
0.79 [0.74e0.83]). When only moderate- or strong-quality studies were considered, the success rate was 0.82
(0.73e0.89). As for the different definitions of vaginismus, studies with unconsummated marriage as the in-
clusion criterion showed the worst success rate (0.68). The origin of vaginismus (primary, secondary, or both), its
duration, the mean age of the participants, the involvement of the partner in the intervention, or the geographic
setting did not exert a significant effect on the outcome. Studies enrolling women with unconsummated marriage
showed a significantly worse success rate.
Clinical Implications: No approach is superior to the others in allowing the achievement of penetrative in-
tercourse in women with vaginismus.
Strength & Limitations: Only studies specifically enrolling patients with vaginismus were selected, and analyses
were performed on an intention-to-treat approach. The main limitations are the small number of trials in the
meta-analysis of RCTs and the lack of a comparison group in the meta-analysis of observational studies, which
cannot rule out a placebo effect. Due to the limited evidence available, great caution is required in the inter-
pretation of results. Further well-designed trials, with more appropriate outcomes than penetrative sex, are
required.
Conclusion: The meta-analysis of RCTs documented a trend toward higher efficacy of active treatment vs
controls, whereas the meta-analysis of observational studies indicated that women with vaginismus benefit from a
range of treatments in almost 80% of cases. Maseroli E, Scavello I, Rastrelli G, et al. Outcome of Medical and

Received January 26, 2018. Accepted October 5, 2018.
1
Sexual Medicine and Andrology Unit, Department of Experimental, Clinical,
and Biomedical Sciences “Mario Serio”, University of Florence, Florence,
Italy;
2
Endocrinology and Medical Sexology, Department of Systems Medicine,
University of Rome Tor Vergata, Rome, Italy;
3
Endocrinology Unit, Medical Department, Azienda Usl Bologna Maggiore-
Bellaria Hospital, Bologna, Italy;
4
Gynecology and Obstetrics Unit, Department of Experimental, Clinical and
Biomedical Sciences “Mario Serio”, University of Florence, Florence, Italy;
5
Istituto Nazionale Biostrutture e Biosistemi, Rome, Italy
Copyright ª 2018, International Society for Sexual Medicine. Published by
Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.jsxm.2018.10.003

J Sex Med 2018;-:1e13 1

2 Maseroli et al
Psychosexual Interventions for Vaginismus: A Systematic Review and Meta-Analysis. J Sex Med
2018;XX:XXXeXXX.
Copyright  2018, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Psychological Interventions; Sexual Pain Disorders; Female; Women; Vaginismus; Genito-Pelvic
Pain/Penetration Disorder; Behavioral Therapy; Cognitive Behavioral Therapy; Botulinum; Meta-Analysis
INTRODUCTION
Premise
Vaginismus is a common condition that strongly impairs the
ability to experience sexual intercourse, with a detrimental effect
on sexual and general health1,2; nevertheless, the evidence on the
efficacy of interventions for vaginismus is lacking. The definition
of vaginismus is currently debated. The spasm-based model,
theorized in the 19th century, was first introduced in the
Diagnostic and Statistical Manual of Mental Disorders (DSM),
Third Edition in 1980 as a “recurrent or persistent involuntary
spasm of the musculature of the outer third of the vagina that
interferes with sexual intercourse.”3 This definition remained
essentially unchanged until the DSM, Fourth Edition, Text
Revision4 in 2000, and has been used in the vast majority of
studies over 3 decades (Table 1 and Supplementary File 1). In
later years, the lack of an empirical demonstration of pelvic
muscle spasm was pointed out,5 and at the Second International
Consultation on Sexual Medicine (ICSM-2) an international
definitions committee proposed a behavioral description of
vaginismus focusing on the inability “to allow vaginal entry
of.any object despite the woman’s expressed wish to do so,”6
which was adopted as the inclusion criterion in several studies
on vaginismus (Table 1 and Supplementary File 1). However,
the notion of vaginismus as a separate disorder persisted.
In the DSM, Fifth Edition, published in 2013, vaginismus was
collapsed with dyspareunia (previously defined as “recurrent or
persistent genital pain associated with sexual intercourse”)4 into
the single diagnostic identity of genito-pelvic pain/penetration
disorder (GPPPD).7 In the GPPPD category, fear of penetration
or pain during penetration are considered as sufficient diagnostic
criteria, independently of the tightening of pelvic muscles.7 This
new categorization has raised some concerns, as some have
argued that vaginismus and dyspareunia are characterized by
different etiologies, clinical presentation, and treatment ap-
proaches.8,9 It is noteworthy that in the still unedited World
Health Organization 11th Revision of the International Classifi-
cation of Diseases, vaginismus will be listed as a separate diagnosis
from dyspareunia (sexual pain-penetration disorder).10 There are
no available completed studies on the treatment of GPPPD at
the present time, likely due to the fact that the update is too
recent to be fully transposed into clinical practice and trials.
Therefore, intending to perform a systematic review and meta-
analysis on the treatment for this condition, we chose to
consider “vaginismus”—and not GPPPD—as the topic of our
study. The possible influence of different definitions of
vaginismus used as inclusion criteria in the considered studies
was carefully assessed.
Prevalence and Etiological Factors
Definitional problems have contributed to the lack of epide-
miologically sound data on the prevalence of vaginismus.
Community estimates range from 0.5e1%.11 Prevalence rates of
30% have been reported in primary care settings,12 increasing up
to 42% in specialized clinics for female sexual disorders.13,14 The
prevalence of GPPPD has not been ascertained yet.
The literature has historically lacked a systemic approach in
the investigation of etiological factors of vaginismus. Several
organic pathologies such as congenital abnormalities, local in-
fections, trauma associated with childbirth, genital surgery or
radiotherapy, and vaginal lesions and tumors have been suggested
as determinants (see review15). Among psychological factors,
sexual abuse,16 a negative attitude toward sexuality,17 and rela-
tionship difficulties18 have been reported to be involved in the
development of vaginismus. However, these hypotheses have not
been confirmed in large empirical studies.
Vaginismus can negatively affect the quality of intimate rela-
tionship and reproductive capacity, leading to non-
consummation of marriage. Furthermore, in cross-sectional
research, women with vaginismus have been reported to
exhibit a high prevalence of psychopathological correlates,
including depression, anxiety, low self-esteem,19,20 insecure
attachment styles,21 histrionic/hysterical traits,22 and alex-
ithymia.23 It remains unclear, however, whether these comor-
bidities are causes or consequences of vaginismus.
Treatment
Despite the relatively high prevalence and the severity of its
negative impact on quality of life, no standardized and etiology-
driven therapeutic interventions have been developed for vagi-
nismus. Indeed, the criticized and changing definitions, the
partial overlap with similar disorders (ie, dyspareunia),24 and the
lack of a clearly established etiology have led to a lack of
good-quality research in proposing and testing treatments.
Accordingly, the available recommendations for the treatment of
vaginismus are not based on evidence provided by randomized
clinical trials (RCT), but on clinical experience and expert
opinions.25,26
In the early 70s, Masters and Johnson and other authors re-
ported up to a 100% of success rate in the treatment for
J Sex Med 2018;-:1e13
J Sex Med 2018;-:1e13

Interventions for Vaginismus

Table 1. Main characteristics of the randomized clinical trials included in the meta-analysis
Drop-
Definition Time since Patients, Partner outs,
Study Setting Design criteria Origin onset, mo ITT Age, y Interventions involved % Successes Other findings
6
ter Kuile The Parallel ICSM-2 Primary 124.92 35 (1) vs 28.9 Therapist-aided exposure Yes 10 31/35 (1) vs Significant
et al,35 Netherlands RCT 35 (2) treatment based on 4/35 (2) reduction in
2013 vaginal penetration fear of coitus
exercises (1) vs waiting (FSQ), coital
list (2) pain (FSFI
pain), and
sexual distress
(FSDS)
Van The Parallel Spasm Primary 132 81 (1) vs 28.6 CBT in written format Yes 20.5 11/81 (1) vs No effect on
Lankveld Netherlands RCT 36 (2) (bibliotherapy) or 0/36 (2) sexual function
et al,36 group format (1) vs (FSFI), general
2006 waiting list (2) life satisfaction,
or sexual
dissatisfaction
(MMQ)
Zarski Germany Parallel Spasm Mixed 64.3 40 (1) vs 25.8 Psychoeducation, Yes 40 10/40 (1) vs Significant
et al,37 RCT 37 (2) cognitive restructuring, 6/37 (2) reduction in
2017 gradual exposure (1) vs fear of coitus
waiting list (2) (FSQ) and
dyadic coping
(DCI)
CBT ¼ cognitive behavioral sex therapy; DCI ¼ Dyadic Coping Inventory (Bodenmann, 200885); FSDS ¼ 12-item Female Sexual Distress Scale (Derogatis et al, 200286); FSFI ¼ Female Sexual Function Index
(Rosen et al, 200087); FSQ ¼ Fear of Sexuality Questionnaire (ter Kuile et al, 200777); ICSM-2 ¼ Second International Consultation on Sexual Medicine; ITT ¼ intention to treat; MMQ ¼ Maudsley Marital
Questionnaire (Arrindell et al, 198388); RCT ¼ randomized clinical trial.

3
4 Maseroli et al
vaginismus with behaviorally oriented sex therapy (see review15);
however, these data have not been replicated and should be
considered in the light of their being low-quality evidence,
mainly because of the lack of controls. Since then, other ap-
proaches were developed, and current options can be divided
into behavioral sex therapy, cognitive behavioral sex therapy
(CBT), pelvic floor physiotherapy, and pharmacological therapy
(local injections of botulin toxin or use of psychiatric drugs, eg,
anxiolytics).27
For many years, most observations on the success of treatments
for vaginismus have been derived from case study reports or case
series. In order to gain more insights into therapeutic options for
vaginismus, existing evidence needs to be systematically collected
and reviewed, possibly with the support offered by the meta-
analytic method, which allows for formal quantitative assess-
ments. Previous systematic reviews included only controlled
studies and found no differences in the efficacy of the considered
interventions.27e29 No data obtained through a meta-analytic
approach considering observational studies or RCTs comparing
active treatments vs controls are currently available.
Aim
The aim of this meta-analysis is to collect and review all in-
formation regarding vaginismus treatment, including data from
RCTs comparing active treatments vs controls and from obser-
vational studies.
METHODS
This meta-analysis was registered on PROSPERO
(CRD42017082296) and is reported following the criteria of the
PRISMA statement30 (Supplementary File 2).
Data Sources and Searches
In order to collect the available studies that evaluated the effect
of treatment for vaginismus, we performed an extensive MED-
LINE, Embase, and PsycInfo search using the words “vagi-
nismus” [MeSH Terms] OR “vaginismus” [All Fields] OR
“unconsummated marriage” [All Fields] OR “non-consummated
marriage” [All Fields], accruing all records on human beings
published up to 30 April 2018. No language restrictions were
introduced. References of included studies and relevant reviews
were also checked for records. Completed but still unpublished
trials were identified through a search of the clinicaltrials.gov
website with the same key words. The identification of rele-
vant abstracts, the selection of studies, and the data extraction
from full-text articles were carried out independently by 2 of the
authors (E.M. and I.S.), and conflicts resolved by a third author
(L.V.).
Study Selection
Only the studies evaluating any therapeutic intervention for
vaginismus were included, independently of the study design
(Figure 1). As in the Cochrane reviews on the topic,27e29 suc-
cessful outcome was defined as the ability to complete sexual
intercourse; therefore, only studies reporting data on this
parameter were selected. Although sexual intercourse represents a
“technical success” that does not equate with full sexual reha-
bilitation, this was considered as the most objectively defined and
reliable indicator across studies.
Diagnostic Criteria for Vaginismus
The possible influence of different definitions used as inclu-
sion criteria (muscle spasm interfering with vaginal penetration;
inability to allow vaginal entry of a penis or any object despite the
woman’s wish, according to ICSM-26; or unconsummated
marriage) was assessed in sensitivity analyses.
For RCTs, only those having no treatment (waiting list con-
trol or placebo) as the comparator were considered eligible, in
order to investigate the net effect of therapy for vaginismus.
Data Extraction and Quality Assessment
Results of unpublished trials were retrieved on clinicaltrials.
gov. The same source was used to complete information on re-
sults of published trials, when not reported in publications.
When no adequate information was available within the papers,
we contacted the investigators for additional information. The
information retrieved for each study included: number of pa-
tients, number of successes, study design, type of intervention,
vaginismus diagnostic method used as inclusion criteria, origin of
vaginismus (primary, secondary, or both), duration of vaginismus
of enrolled patients at the beginning of the study, mean age, and
the involvement of the partner in the intervention (Table 1 for
RCTs and Supplementary File 1 for observational studies).
The quality of trials was assessed using the Cochrane criteria.31
Specifically, the Effective Public Health Practice Project quality
assessment tool for quantitative studies32 was used to rate the
quality of observational studies, and the GRADE approach
proposed by Jadad et al33 was used to describe the quality of
RCTs. For RCTs, we evaluated how the randomization sequence
was generated, how allocation was concealed, follow-up rates,
description of drop-outs and withdrawals, whether the analyses
were by intention to treat, and the adequate listing of eligibility
criteria (Table 2a). For observational studies, the following
criteria were evaluated: selection bias (probability of the sample
of being representative of the target population and rates of
participation), quality of the study according to the design, val-
idity and reliability of instruments used for data collection,
follow-up rates, and description of drop-outs and withdrawals
(Table 2b).
Data Synthesis and Analysis
The primary outcome was the success rate (number of suc-
cesses/total sample) in the completion of sexual intercourse.
Hypnotherapy, systematic de-sensitization using vaginal dilators
J Sex Med 2018;-:1e13
Interventions for Vaginismus 5

Idenficaon
Records idenfied through Addional records idenfied
database searching through other sources
(n = 775 ) (n = 7 )

Records aer duplicates removed

(n = 384 )
Screening

Records screened Records excluded

(n = 398) (n = 101)

Full-text arcles assessed Full-text arcles excluded,

for eligibility with reasons
Eligibility

(n = 297) (no treatment n = 194)

(reviews n = 7)

Studies included in
qualitave synthesis
(n = 50)
Included

Studies included in
quantave synthesis
(meta-analysis)
(n = 43 observaonal
studies, n = 3 RCTs)

Figure 1. Trial flow diagram for the selection of observational studies and randomized clinical trials (RCTs) evaluating any therapeutic
intervention for vaginismus and reporting data on the completion of intercourse. For RCTs, only those having no treatment (waiting list
control or placebo) as the comparator were considered eligible. From PRISMA 2009 flow diagram.30

or self-exploration, sensate focusing, Kegel and Paula Garburg
muscle exercises, and muscle relaxation have been merged and
considered as behavioral sex therapy interventions, separately
from CBT, in which these behavioral elements are part of a
broader approach involving cognitive restructuring.34 Partners
were considered as involved in the treatment process whenever
specified by the investigators.
In the analysis of RCTs, the strength of the association
between treatment and outcome was expressed by the odds
ratio for the attainment of successful intercourse in treated vs
untreated (waiting list) patients. For the analysis of the
observational studies, the success rate was considered as the
effect size. Moderators were reported as percentage when
categorical or mean ± SD when continuous variables. When
values for each subject were reported, prevalence or mean was
calculated. All analyses were performed using software
(Comprehensive Meta-analysis, Version 2; Biostat, Engle-
wood, NJ, USA).

Table 2a. Quality of randomized clinical trials included in the meta-analysis

Double Withdrawals and Jadad et al33 Intention Eligibility
Study Design Randomization blinding drop-outs score to treat criteria listed

ter Kuile et al,35 2013 Parallel 1þ1 0 1 3/5 Yes Yes

Van Lankveld et al,36 2006 Parallel 0 0 1 1/5 Yes Yes
Zarski et al,37 2017 Parallel 1þ1 0 1 3/5 Yes Yes

J Sex Med 2018;-:1e13

6 Maseroli et al

Table 2b. Qualitative characteristics of the observational studies included in the meta-analysis
Study Selection bias Study design Data collection Drop-out and withdrawal Global rating

Barnes,38 1986 Weak Weak Weak Strong Weak

Barnes et al,39 1984 Weak Moderate Weak Strong Weak
Ben-Zion et al,40 2007 Weak Weak Weak Strong Weak
Bertolasi et al,41 2009 Moderate Moderate Moderate Strong Strong
Biswas and Ratnam,42 1995 Weak Weak Weak Strong Weak
Davidson and Yftach,43 1976 Moderate Weak Weak Strong Weak
Dawkins and Taylor,44 1961 Weak Weak Weak Weak Weak
Drenth et al,45 1996 Moderate Weak Weak Weak Weak
Duddle,46 1977 Weak Weak Weak Strong Weak
Ellison,47 1968 Weak Weak Weak Strong Weak
Engman et al,48 2010 Moderate Weak Moderate Weak Weak
Fageeh,49 2011a Moderate Weak Weak Strong Weak
Fageeh,49 2011b Moderate Weak Weak Strong Weak
Fuchs et al,50 1980 Weak Weak Weak Weak Weak
Ghazizadeh and Nikzad,51 2004 Moderate Moderate Weak Strong Moderate
Grillo and Grillo,52 1980 Weak Weak Weak Strong Weak
Gül and Ruf,53 2009 Weak Weak Weak Strong Weak
Hall,54 1952 Weak Weak Weak Strong Weak
Harrison,55 1996 Moderate Weak Weak Strong Weak
Hawton et al,56 1986 Moderate Weak Moderate Strong Moderate
Hawton and Catalan,18 1990 Moderate Weak Moderate Strong Moderate
Jeng et al,57 2006 Moderate Moderate Weak Strong Moderate
Jindal and Jindal,58 2010 Moderate Moderate Weak Weak Weak
Kabakci and Batur,59 2003 Weak Moderate Moderate Weak Weak
Kennedy et al,60 1995 Weak Moderate Moderate Weak Weak
Lamont,61 1978 Moderate Weak Weak Strong Weak
Mikhail,62 1976 Weak Weak Weak Strong Weak
Molaeinezhad et al,63 2014 Moderate Moderate Moderate Strong Moderate
Muammar et al,64 2015 Weak Weak Moderate Strong Weak
Munasinghe et al,65 2004 Weak Moderate Moderate Weak Weak
O’Sullivan,66 1979 Weak Weak Weak Weak Weak
O’Sullivan and Barnes,67 1978 Weak Weak Weak Weak Weak
Pacik and Geletta,68 2017 Moderate Moderate Moderate Weak Moderate
Ramzy et al,69 NCT01859507 Moderate Moderate Weak Strong Moderate
Reamy,70 1982 Moderate Weak Weak Strong Weak
Reissing et al,71 2013 Weak Weak Moderate Strong Weak
Scholl,72 1988 Weak Weak Weak Strong Weak
Seo et al,73 2005 Moderate Weak Moderate Strong Moderate
Shafik and El-Sibai,74 2000 Moderate Moderate Weak Weak Weak
ter Kuile et al,75 2009 Moderate Weak Moderate Weak Weak
Yasan and Akdeniz,76 2009 Moderate Moderate Weak Weak Weak

Randomized Clinical Trials
The heterogeneity between the RCTs retrieved was tested and
it resulted as being high (I2 ¼ 85.95, P < .001). Hence, we
employed a random effect model for the calculation of the pooled
odds ratio.
Observational Studies
Heterogeneity across studies for the successful attainment of
sexual intercourse was quantified using I2 statistics (the per-
centage of variation across studies). Considering that I2 was
68.59 (P < .0001), we employed a random effect model for the
calculation of effect size, incorporating an assumption that the
different studies are estimating different, yet related, intervention
effects. Meta-regression analyses were performed to test the effect
on the achievement of sexual intercourse of: (1) reported time
since the onset of vaginismus, (2) age at observation, and (3) the
year of publication of the study. Subgroup analyses were carried
out considering: (1) different interventions (behavioral sex ther-
apy vs CBT vs pharmacological therapy vs pelvic floor physio-
therapy); (2) characteristics pertaining to the study population
[primary vs acquired vs mixed (acquired and primary) vagi-
nismus]; (3) definition criteria for vaginismus (muscle spasm vs

J Sex Med 2018;-:1e13

Interventions for Vaginismus
ICSM-2 definition6 vs unconsummated marriage); (4) active
involvement of the partner in the therapeutic process or not; (5)
study design (prospective vs retrospective vs RCT); and (6)
geographic setting (United States and Europe vs Africa, Middle
East, and Asia).
RESULTS
Available Studies Description
The search produced 775 potentially relevant citations. After
screening and detailed assessment, 3 RCTs (involving a total of
264 subjects, mean age 27.76 years)35e37 and 43 observational
studies (involving a total of 1,660 subjects, mean age 27.07
years)18,38e76 were included in the final analysis. None of the
RCTs included placebo arms, but only waiting list controls as the
comparator. The flow chart of studies is reported in Figure 1;
detailed characteristics are reported in Tables 1 and 2a (RCTs)
and Supplementary File 1 and Table 2b (observational studies).
RCTs Outcomes
CBT was used in 2 studies, whereas behavioral sex therapy in
1 study only. Active treatment showed a trend toward a signif-
icantly better result vs the comparator (Mantel Haenszel 10.27
[95% CI 0.79e133.5], P ¼ .075) (Figure 2). The Begg-adjusted
rank correlation test (Kendall s ¼ 0.33, P < .60) did not suggest
the presence of publication bias and the trim and fill test did not
identify any missing studies.
Secondary Outcome
2 Studies35,37 reported fear of coitus as assessed pre- and
post-treatment using a validated tool (Fear of Sexuality Question-
naire77) (Table 1). By meta-analyzing this outcome, no difference
between active treatment and waiting list was observed (difference in
means 0.4 [lower limit e0.9; upper limit e1.7], P ¼ .60).
Observational Studies Outcomes
The combination of the results obtained from studies
included in the meta-analysis showed that the treatment of
vaginismus is associated with the completion of sexual pene-
trative intercourse in 79% of cases independently of the
Figure 2. Odds ratio and 95% CI for the attainment of successful intercourse in treated vs untreated patients in randomized clinical trials
examining treatment for vaginismus. WLC ¼ waiting list controls.
J Sex Med 2018;-:1e13
7
therapy used [success rate 0.79 (0.74e0.83)] (Table 3 and
Supplementary File 3). The Begg-adjusted rank correlation test
(Kendall s ¼ 0.33, P < .05) suggested the presence of
publication bias; in particular, the trim and fill test identified
14 missing studies (Figure 3). Inferring their presence pro-
vided a success rate of 0.73 (0.67e0.78).
In order to investigate the factors possibly affecting the success
rate, meta-regression analyses were performed. No correlation
was found between therapeutic success and the age at study entry
(slope [s] ¼ 0.01, P ¼ .60; intercept [I] ¼ 0.61, P ¼ .39),
duration of vaginismus (s ¼ 0.01, P ¼ .43; I ¼ 0.79, P <
.0001), or the year of publication of the study (s ¼ 0.01, P ¼
.71; I ¼ e0.42, P ¼ .83).
Sensitivity Analyses
Study Quality
When only moderate- (n ¼ 8) or strong-quality (n ¼ 1)
studies were considered for the analysis (Table 2b), success rate
was 0.82 (0.73e0.89).
Kind of Intervention
When different treatments were considered, we found that the
most widespread approach was psychological therapy; specif-
ically, behavioral sex therapy was employed in 22 studies,
whereas CBT was employed in 9 studies.38,43,48,53,55,59,60,63,65
Concerning pharmacological treatments, the majority of the
studies investigated the effect of botulinum toxin local injections
(used in 641,49,51,68,69,74 out of 7 studies) whereas only 162
considered the effect of therapy with diazepam intravenously. 4
studies reported the effect of pelvic floor physiotherapy39,54,71,73;
only 1 study evaluated the surgical removal of hymenal rem-
nants,52 hence this therapy was not considered for the compar-
ison between different therapies. Another study38 was excluded
from this sub-analysis because it assessed the effect of psycho-
therapy and pelvic floor physiotherapy, but this latter was used
only in 5 out of 55 subjects and the proportion of successes in
women undergoing only psychotherapy or both therapies was
not specified in the article. We did not find any significant
8 Maseroli et al

Table 3. Rates (with 95% CI) of completion of sexual intercourse upon treatment for vaginismus, overall and according to different
possible predictors (data from observational studies)
Studies Subjects Event rate Lower limit of CI Upper limit of CI

Behavioral sex therapy 22 962 0.79 0.72 0.85 Q ¼ 1.74, P ¼ .63

CBT 9 271 0.77 0.68 0.84
Pharmacological therapy 7 354 0.75 0.68 0.81
Pelvic floor physiotherapy 4 56 0.88 0.56 0.97
Removal of hymenal remnants* 1 17 0.94 0.68 0.99

Prospective studies 14 720 0.77 0.69 0.83 Q ¼ 0.05 P ¼ .82

Retrospective studies 29 940 0.79 0.72 0.84

Primary vaginismus 21 735 0.79 0.71 0.85 Q ¼ 0.01, P ¼ .97

Mixed population 11 612 0.79 0.70 0.86
Secondary vaginismus* 1 39 0.69 0.53 0.82

Muscle spasm 33 1,074 0.81 0.75 0.85 Q ¼ 8.25, P ¼ .02

ICSM-2 definition6 6 411 0.78 0.60 0.89
Unconsummated marriage 4 175 0.68 0.75 0.85

Partner involved 32 1,333 0.80 0.75 0.85 Q ¼ 1.04, P ¼ .31

Partner not involved 10 308 0.75 0.63 0.84

United States and Europe 26 1,074 0.76 0.71 0.80 Q ¼ 1.06, P ¼ .30
Africa, Middle East, Asia 13 527 0.82 0.71 0.89
Overall 43 1,660 0.79 0.74 0.83
CBT ¼ cognitive behavioral sex therapy; ICSM-2 ¼ Second International Consultation on Sexual Medicine; Q ¼ Q value.
*Group not included in the sensitivity analysis because it consisted of only 1 study.

difference among the kinds of intervention (Q value [Q] ¼ 1.74,
P ¼ .63); similar results were observed when only studies using
botulinum local injections41,49,51,68,69,74 were considered among
the ones on pharmacological therapy (success rate 0.78
[0.74e0.83]; Q ¼ 1.65, P ¼ .65).
Other Potential Moderators
No significant differences were found when stratifying the studies
according to the study design (prospective39,41,51,57e60,63,65,68,69,74e76
or retrospective18,38,40,42e50,52e56,61e62,64,66,67,70e73; Q ¼ 0.05,
P ¼ .82) (Table 3).

Figure 3. Funnel plot of observational trials examining the effects of different treatment for vaginismus on completion of intercourse.

J Sex Med 2018;-:1e13

Interventions for Vaginismus
Insufficient studies were available to compare women
with secondary vaginismus to those with primary vaginismus;
therefore, the studies reporting the dysfunction as pri-
mary39,42e47,51e53,57e60,63,67,71,72,74e76 were compared to the
ones with a mixed population,40,48,49,55,61,64,65,68,70 showing no
statistically significant difference (Q ¼ 0.01, P ¼ .97) (Table 3).
Interestingly, a significant difference was found when stratifying
the studies according to the different definitions of vaginismus
(muscle spasm vs ICSM-2 definition6 vs unconsummated mar-
riage; Q ¼ 8.25, P ¼ .02) (Table 3). Studies reporting uncon-
summated marriage as the inclusion criterion43,44,46,58 showed
the worst success rate (0.68) (Table 3).
The active involvement of the partner in the therapeutic process
did not exert a significant effect on the therapeutic outcome
(Q ¼ 1.04, P ¼ .31) (Table 3). Similarly, we did not find sig-
nificant differences between studies performed in the United
States or Europe18,38e41,43e48,50,52,54e56,60e62,66e68,70e72,75
compared with studies from Africa, the Middle East, and
Asia42,49,51,53,57e59,63e65,69,73,74,76 (Q ¼ 1.06, P ¼ .30)
(Table 3). Finally, when only studies enrolling 10 sub-
jects18,38,40e52,54e61,63e73,75,76 were considered for the analysis,
success rate was 0.78 (0.73e0.82).
DISCUSSION
Vaginismus has been traditionally conceptualized as an easily
treatable condition, mainly based on expert opinion. Our data,
providing a quantitative measure of achievement of successful
intercourse with different therapies, only partly support this view.
Indeed, the meta-analysis of RCTs showed that psychological
therapies do not significantly increase the probability of suc-
cessful intercourse compared to controls, although a trend to-
ward significance was observed. The lack of a clear effect could be
due to the limited number of studies. On the other hand, the
meta-analysis of observational studies demonstrated an overall
high cumulative success rate (79%); specifically, the most rep-
resented regimen, behavioral sex therapy, obtained a success rate
of 79%. When only higher quality studies were considered, the
success rate reached 82%.
In 2012, the last Cochrane systematic review on interventions
for vaginismus could not provide meta-analytic data on the ef-
ficacy of therapy for vaginismus compared to groups not involved
in active treatments due to the lack of more than 1 study with a
no-treatment arm.29 They only were able to conclude that,
despite the limited evidence, there was no difference between
systematic de-sensitization (a kind of behavioral therapy) and any
of the control interventions.29 Therefore, this is the first meta-
analysis on RCTs on active vs inactive control conditions on
the topic.
The first RCT investigating the efficacy of treatment for
vaginismus was published in 2006.36 117 Women with lifelong
vaginismus were randomly assigned to CBT delivered in a group
format, in written format (bibliotherapy), or to a waiting list
J Sex Med 2018;-:1e13
9
control group.36 CBT was efficacious, with 14% of the treated
participants obtaining successful intercourse vs none of the par-
ticipants in the control group, but with a small effect size.36
Some years later, ter Kuile and colleagues35 investigated the ef-
ficacy of therapist-aided exposure (vaginal penetration behavioral
exercises) in 70 women with lifelong vaginismus randomly
allocated to intervention or waiting list control group. They
found that 89% of subjects had sexual intercourse at post-
treatment compared with 11% in the control condition.35
Finally, in 2017, Zarski and colleagues37 evaluated the efficacy
of an Internet-based guided self-help intervention (including
cognitive restructuring) in a RCT of 77 women with vaginismus
for an average duration of 6 years. At 6 months, only the treated
group showed a significant increase in intercourse penetration.37
Overall, these findings suggest a positive effect of treatment.
RCTs are the gold standard for investigating the efficacy of
medical treatments, and meta-analyses restricted to RCTs are
generally preferred; however, publication of meta-analyses con-
cerning observational studies has increased substantially in the
last decades, due to the pressure for informed decisions in clinical
practice. Observational data lack the experimental element of a
random allocation, but may be needed to assess the effectiveness
of an intervention in a community as opposed to the special
setting of controlled trials.78 Despite being more exposed to
biases and interpretation difficulties, meta-analyses of observa-
tional studies are recognized as an important method for
assessing effectiveness. This becomes crucial in the context of
treatment for vaginismus, a common condition with a detri-
mental impact on the individual and their relationships for which
evidence-based recommendations are urgently needed and only a
few, moderate-quality RCTs are available. Our meta-analysis of
observational studies suggests the effectiveness of available
treatments for vaginismus. Although this finding is derived from
records globally rated as “weak” for the most part, it has to be
noted that a similar—actually, higher—success rate was found
when restricting the analysis to studies judged as “moderate” or
“strong.” In this regard, in many cases the “weak” global rating
had to be assigned because of the uncertain validity and/or
reliability of data collection methods (ie, lack of validated tests
used as outcome measures); however, the only information
related to the outcome measures that we extracted was the
completion of intercourse, for which a standardized tool of
evaluation that is not the achievement as self-reported by the
patient (or the couple) has not been developed. Therefore, in our
view, the data collection bias does not significantly impair the
quality of the studies, insofar as this meta-analysis’s results are
concerned.
With respect to the different kind of interventions, we found
that behavioral sex therapy, CBT, pharmacological therapy,
pelvic floor physiotherapy, and removal of hymenal remnants are
all successful; nevertheless, it has to be noted that the number of
studies, in particular assessing the last 2 kinds of treatments, is
very limited. Behavioral sex therapy, on the other hand, has
10
emerged as the most common kind of intervention. Based on the
circular fear-avoidance model of vaginismus, the rationale of this
therapy is that, by reducing avoidance behavior and increasing
successful penetration model behavior, erroneous cognitions can
be eliminated.79 CBT, in which gradual exposure exercises
typical of behavioral therapy are part of a broader approach
involving cognitive restructuring,77,80 is considered as one of the
most promising and complete therapies for vaginismus, generally
accepted in clinical practice.34 Without etiology-driven treat-
ments, psychological therapies represent a rational and integrated
choice, addressing a dysfunctional pattern that tends to establish
itself in women with vaginismus regardless of the causative factor.
Conversely, pelvic floor physiotherapy and local medical treat-
ments focus on the symptom, aiming, respectively, to develop
awareness of the vaginal musculature and to decrease its hyper-
tonicity pharmacologically (or surgically). Despite the apparent
theoretical superiority of psychological therapies, we did not
observe a significantly superior success rate of these techniques
over the other treatments. Noteworthy, we found that local in-
jections of botulinum toxin are apparently gaining popularity,
according to recently completed or recruiting intervention
studies registered in the U.S. National Library of Medicine
clinicaltrials.gov database.
When computing the effect of types of vaginismus (primary
vs both primary and secondary), we were not able to observe
any statistically significant difference in the success rate. It has
been reported that women with primary and secondary vagi-
nismus show a different treatment history; in particular,
women with secondary vaginismus are more likely to have
received pharmacological interventions and to have tried a
greater range of interventions.81 In our sub-analysis, the limited
number of studies only allowed a comparison between the re-
cords reporting vaginismus as primary with the ones with a
mixed population (primary and secondary), without detecting
any difference in the outcome. We also did not find a corre-
lation between the involvement of the partner in the thera-
peutic process and resolution of vaginismus. However, it
should be recognized that only 1 small controlled retrospective
study was specifically designed to investigate this issue by
comparing regular couple sexual therapy vs therapy with a
surrogate partner.40 In this study, treating vaginismus with a
surrogate partner was found to be at least as effective as couple
therapy,40 thus suggesting that the presence of a cooperative
partner in the usual therapeutic process might not play a major
role in predicting the outcome.
As for definitions of vaginismus, we found that studies
enrolling women with unconsummated marriage—thus, likely
affected by primary vaginismus—as the inclusion criterion
showed a significantly worse success rate than the other studies.
Because of the fact that, as previously mentioned, the efficacy of
treatment does not seem to depend on the characteristics of the
condition (namely primary or secondary vaginismus), specific
aggravating factors may play a part in this category of patients. It
has been reported that unconsummated marriage involves
Maseroli et al
religious and cultural taboos and unique psychological implica-
tions resulting from marital and fertility issues, sense of guilt, and
social and familial pressures.82 The associated distress is likely to
interfere significantly with a positive treatment outcome.
It was previously hypothesized that in some areas, such as the
Middle East, cultural background influences vaginismus treat-
ment.83 However, our data did not show differences in the
outcome depending on the geographic setting of the study or the
year of publication.
Our work also indicated an ongoing need for more and better
research on treatment for vaginismus. The number of available
RCTs on the topic is extremely limited, and there are no ongoing
registered trials (according to the ClinicalTrials.gov registry).
Nevertheless, it should be recognized that high-quality evidence
on vaginismus treatment is difficult to produce, given the defi-
nitional shortcomings and our limited knowledge on its causative
mechanisms.
The present work has important limitations, the main ones
being the small number of trials of the meta-analysis of RCTs,
the use of mixed treatments, and the already mentioned inherent
flaws of the meta-analysis of observational studies. The lack of a
comparison group cannot rule out that vaginismus could be
meaningfully affected by a placebo effect.84 Accordingly, the
meta-analysis of the RCTs did not show a clearly greater effect of
psychological therapies over controls. Moreover, women with
vaginismus, who have been reported to show higher histrionic
personality traits—characterized by attention seeking—than
women with other sexual symptoms,22 could be easily influenced
by the simple fact of being evaluated or included in a study. The
ideal design for addressing this point is the placebo-controlled
RCT; so far, such studies are not present and apparently, not
even ongoing. Finally, the lack of long-term follow-up data and
relapse rates and the heterogeneity of vaginismus diagnostic
criteria have to be considered as limitations.
It should also be noted that the success of treatment is ques-
tionable if limited to vaginal penetration. The leading authors
and clinical experts in this field (eg, ter Kuile75) perceive pene-
trative sex as partial success, and suggest that rehabilitation
therapies focused on sexual intercourse as the goal are likely to
fail and lead to recurring problems. It is mandatory for future
therapeutic challenges to address the goal of improving sexual
experience as well as satisfaction in women with vaginismus.
As far as possible, we tried to limit the impact of methodo-
logical biases, by ensuring a comprehensive search of multiple
sources (including trial registries) and including also subjects who
discontinued therapy or dropped out from the study. This
approach is conservative for outcomes related to treatment suc-
cess rate; in fact, those participants who withdrew from the
studies before the end point were assumed to have not responded
to treatment. The trim and fill method was used to create a
funnel plot that included both the available studies and the
imputed studies, in order to evaluate the effect size shifts when
the imputed studies are included. Taking into account the trim
J Sex Med 2018;-:1e13
Interventions for Vaginismus
and fill adjustment for the meta-analysis of observational studies,
the overall event rate was lower but fairly close to the original
(0.73 vs 0.79); in this context, a success rate of 73% has the same
substantive implications as a success rate of 79%. In the meta-
analysis of RCTs, no publication biases were detected. Another
strength of our meta-analysis is that we only selected studies
specifically enrolling patients with vaginismus, thus excluding
articles that investigate mixed populations (ie, dyspareunia, vul-
vodynia, and vaginismus).
CONCLUSION
In conclusion, our meta-analysis of RCTs showed that psy-
chological therapies do not significantly increase the probability
of successful intercourse compared to controls, although a trend
toward significance was observed. The meta-analysis of obser-
vational studies indicates that women with vaginismus benefit
from a range of treatments (behavioral sex therapy, CBT, phar-
macological therapy, pelvic floor physiotherapy, and removal of
hymenal remnants) in almost 80% of cases; no approach has
proven superior to the others in allowing the achievement of
penetrative intercourse. Only a comparison between studies on
primary vaginismus and studies on mixed populations (primary
and secondary) was possible, which did not highlight significant
differences; however, we found that studies on women with
unconsummated marriage showed a significantly worse
success rate.
Due to the limited evidence available, great caution is required
in the clinical interpretation of results. Further well-designed
trials, with more appropriate outcomes than merely penetrative
sex, are required to draw definitive conclusions on the efficacy of
interventions for vaginismus, and this does not seem likely to
happen in the next few years.
Corresponding Author: Linda Vignozzi, MD, PhD, Sexual
Medicine and Andrology Unit, Department of Experimental,
Clinical, and Biomedical Sciences “Mario Serio”, University of
Florence, Viale Pieraccini 6, 50139 Florence, Italy. Tel:
390552758429; Fax: 390552758411; E-mail: linda.vignozzi@
unifi.it
Conflict of Interest: The authors report no conflicts of interest.
Funding: None.
STATEMENT OF AUTHORSHIP
Category 1
(a) Conception and Design
Elisa Maseroli; Linda Vignozzi
(b) Acquisition of Data
Elisa Maseroli; Irene Scavello; Sarah Cipriani
(c) Analysis and Interpretation of Data
Elisa Maseroli; Irene Scavello; Erika Limoncin; Mario Maggi;
Linda Vignozzi
J Sex Med 2018;-:1e13
11
Category 2
(a) Drafting the Manuscript
Elisa Maseroli; Irene Scavello; Erika Limoncin; Linda Vignozzi
(b) Revising It for Intellectual Content
Elisa Maseroli; Irene Scavello; Giulia Rastrelli; Erika Limoncin;
Giovanni Corona; Angela Magini; Massimiliano Fambrini;
Emmanuele A. Jannini; Mario Maggi; Linda Vignozzi
Category 3
(a) Final Approval of the Completed Manuscript
Elisa Maseroli; Mario Maggi; Linda Vignozzi
REFERENCES
1. Cherner RA, Reissing ED. A comparative study of sexual
function, behavior, and cognitions of women with lifelong
vaginismus. Arch Sexual Behav 2013;42:1605-1614.
2. Pacik PT. Understanding and treating vaginismus: a multi-
modal approach. Int Urogynecol J 2014;25:1613-1620.
3. American Psychiatric Association. Diagnostic and statistical
manual of mental disorders. 3rd ed. Washington, DC: Amer-
ican Psychiatric Publishing; 1980.
4. American Psychiatric Association. Diagnostic and statistical
manual of mental disorders; 4th ed. Text revision. Washington,
DC: American Psychiatric Publishing; 2000.
5. Reissing ED, Binik YM, Khalifé S, et al. Vaginal spasm, pain,
and behavior: an empirical investigation of the diagnosis of
vaginismus. Arch Sex Behav 2004;33:5-17.
6. Basson R, Leiblum S, Brotto L, et al. Revised definitions of
women’s sexual dysfunction. J Sex Med 2004;1:40-48.
7. American Psychiatric Association. Diagnostic and statistical
manual of mental disorders. 5th ed. Arlington, VA: American
Psychiatric Publishing; 2013.
8. Borg C, de Jong PJ, Weijmar Schultz W. Vaginismus and
dyspareunia: automatic vs deliberate disgust responsivity. J
Sex Med 2010;7:2149-2157.
9. Reissing E, Borg C, Spoelstra SK, et al. “Throwing the baby
out with the bathwater”: the demise of vaginismus in favor of
genito-pelvic pain/penetration disorder. Arch Sex Behav 2014;
43:1209-1213.
10. Reed GM, Drescher J, Krueger RB, et al. Disorders related to
sexuality and gender identity in the ICD-11: revising the ICD-10
classification based on current scientific evidence, best clinical
practices, and human rights considerations. World Psychiatry
2016;15:205-221.
11. Fugl-Meyer AR, Sjogren Fugl-Meyer K. Sexual disabilities,
problems, and satisfaction in 18-74 year old Swedes. Scand J
Sex 1999;3:79-105.
12. Read S, King M, Watson J. Sexual dysfunction in primary
medical care: prevalence, characteristics and detection by the
general practitioner. J Public Health Med 1997;19:387-391.
13. Oniz A, Keskinoglu P, Bezircioglu I. The prevalence and causes
of sexual problems among premenopausal Turkish women. J
Sex Med 2007;4:1575-1581.
12
14. Nusbaum MR, Gamble G, Skinner B, et al. The high prevalence
of sexual concerns among women seeking routine gyneco-
logical care. J Fam Pract 2000;49:229-232.
15. Lahaie MA, Boyer SC, Amsel R, et al. Vaginismus: a review of
the literature on the classification/diagnosis, etiology and
treatment. Womens Health (Lond) 2010;6:705-719.
16. Reissing ED, Binik YM, Khalifé S, et al. Etiological correlates of
vaginismus: sexual and physical abuse, sexual knowledge,
sexual self-schema, and relationship adjustment. J Sex
Marital Ther 2003;29:47-59.
17. Basson R. Lifelong vaginismus: a clinical study of 60
consecutive cases. J SOGC 1996;18:551-561.
18. Hawton K, Catalan J. Sex therapy for vaginismus: character-
istics of couples and treatment outcome. Sex Marital Ther
1990;5:39-48.
19. Basson R, Leiblum S, Brotto L, et al. Definitions of women’s
sexual dysfunction reconsidered: advocating expansion and
revision. J Psychosom Obstet Gynaecol 2003;24:221-229.
20. Bodenmann G, Ledermann T, Blattner D, et al. Associations
among everyday stress, critical life events, and sexual prob-
lems. J Nerv Ment Dis 2006;194:494-501.
21. Ciocca G, Limoncin E, Di Tommaso S, et al. Attachment styles
and sexual dysfunctions: a case-control study of female and
male sexuality. Int J Impot Res 2015;27:81-85.
22. Maseroli E, Scavello I, Cipriani S, et al. Psychobiological cor-
relates of vaginismus: an exploratory analysis. J Sex Med
2017;14:1392-1402.
23. Ciocca G, Limoncin E, Di Tommaso S, et al. Alexithymia and
vaginismus: a preliminary correlation perspective. Int J Impot
Res 2013;25:113-116.
24. Borg C, de Jong PJ, Weijmar Schultz W. Vaginismus and
dyspareunia: relationship with general and sex-related moral
standards. J Sex Med 2011;8:223-231.
25. Fugl-Meyer KS, Bohm-Starke N, Damsted Petersen C, et al.
Standard operating procedures for female genital sexual pain.
J Sex Med 2013;10:83-93.
26. Weijmar Schultz W, Basson R, Binik Y, et al. Women’s sexual
pain and its management. J Sex Med 2005;2:301-316.
27. McGuire H, Hawton K. Interventions for vaginismus. Cochrane
Database Syst Rev 2001;2:CD001760.
28. McGuire H, Hawton K. Interventions for vaginismus. Cochrane
Database Syst Rev 2003;1:CD001760.
29. Melnik T, Hawton K, McGuire H. Interventions for vaginismus.
Cochrane Database Syst Rev 2012;12:CD001760.
30. Moher D, Liberati A, Tetzlaff J, et al; The PRISMA Group.
Preferred reporting items for systematic reviews and meta-
analyses: the PRISMA statement. PLoS Med 2009;
6:e1000097.
31. Higgins JPT, Green S, eds. Cochrane handbook for systematic
reviews of interventions. Version 5.1.0. Chichester, UK: John
Wiley & Sons Inc; 2011.
32. Thomas BH, Ciliska D, Dobbins M, Micucci S. Quality
assessment tool for quantitative studies. Hamilton, Ontario,
Canada: Effective Public Health Practice Project; 1998.
Maseroli et al
33. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of
reports of randomized clinical trials: is blinding necessary?
Control Clin Trials 1996;17:1-12.
34. ter Kuile MM, Both S, van Lankveld JJ. Cognitive behavioral
therapy for sexual dysfunctions in women. Psychiatr Clin
North Am 2010;33:595-610.
35. ter Kuile MM, Melles R, de Groot HE, et al. Therapist-aided
exposure for women with lifelong vaginismus: a randomized
waiting-list control trial of efficacy. J Consult Clin Psychol
2013;81:1127-1136.
36. van Lankveld JJ, ter Kuile MM, de Groot HE, et al. Cognitive-
behavioral therapy for women with lifelong vaginismus: a
randomized waiting-list controlled trial of efficacy. J Consult
Clin Psychol 2006;74:168-178.
37. Zarski AC, Berking M, Fackiner C, et al. Internet-based guided
self-help for vaginal penetration difficulties: results of a ran-
domized controlled pilot trial. J Sex Med 2017;14:238-254.
38. Barnes J. Primary vaginismus (part 1): social and clinical fea-
tures. Ir Med J 1986;79:59-62.
39. Barnes J, Bowman EP, Cullen J. Biofeedback as an adjunct to
psychotherapy in the treatment of vaginismus. Biofeedback
Self Regul 1984;9:281-289.
40. Ben-Zion I, Rothschild S, Chudakov B, et al. Surrogate versus
couple therapy in vaginismus. J Sex Med 2007;4:728-733.
41. Bertolasi L, Frasson E, Cappelletti JY, et al. Botulinum neuro-
toxin type A injections for vaginismus secondary to vulvar
vestibulitis syndrome. Obstet Gynecol 2009;114:1008-1016.
42. Biswas A, Ratnam SS. Vaginismus and outcome of treatment.
Ann Acad Med Singapore 1995;24:755-758.
43. Davidson S, Yftach R. The therapy of the unconsummated
marriage. Psychotherapy Theory Res Pract 1976;13:418-419.
44. Dawkins S, Taylor R. Non-consummation of marriage. A sur-
vey of seventy cases. Lancet 1961;278:1029-1033.
45. Drenth JJ, Andriessen S, Heringa MP, et al. Connections be-
tween primary vaginismus and procreation: some observa-
tions from clinical practice. J Psychosom Obstet Gynaecol
1996;17:195-201.
46. Duddle M. Etiological factors in the unconsummated marriage.
J Psychosom Res 1977;21:157-160.
47. Ellison C. Psychosomatic factors in the unconsummated
marriage. J Psychosom Res 1968;12:61-65.
48. Engman M, Wijma K, Wijma B. Long-term coital behavior in
women treated with cognitive behavior therapy for superficial
coital pain and vaginismus. Cogn Behav Ther 2010;39:193-202.
49. Fageeh WM. Different treatment modalities for refractory vagi-
nismus in western Saudi Arabia. J Sex Med 2011;8:1735-1739.
50. Fuchs K. Therapy of vaginismus by hypnotic desensitization.
Am J Obstet Gynecol 1980;137:1-7.
51. Ghazizadeh S, Nikzad M. Botulinum toxin in the treatment of
refractory vaginismus. Obstet Gynecol 2004;104:922-925.
52. Grillo L, Grillo D. Management of dyspareunia secondary to
hymenal remnants. Obstet Gynecol 1980;56:510-514.
53. Gül V, Ruf GD. Treating vaginismus in Turkish women. Ner-
venarzt 2009;80:288-294.
J Sex Med 2018;-:1e13
Interventions for Vaginismus
54. Hall SP. Vaginismus as a cause of dyspareunia; a report of
cases and a method of treatment. West J Surg Obstet
Gynecol 1952;60:117-120.
55. Harrison CM. Le vaginisme. Contracept Fertil Sex 1996;
24:223-228.
56. Hawton K, Catalan J, Martin P, et al. Long-term outcome of
sex therapy. Behav Res Ther 1986;24:665-675.
57. Jeng CJ, Wang LR, Chou CS, et al. Management and
outcome of primary vaginismus. J Sex Marital Ther 2006;
32:379-387.
58. Jindal UN, Jindal S. Use by gynecologists of a modified
sensate focus technique to treat vaginismus causing infertility.
Fertil Steril 2010;94:2393-2395.
59. Kabakçi E, Batur S. Who benefits from cognitive behavioral
therapy for vaginismus? J Sex Marital Ther 2003;29:277-288.
60. Kennedy P, Doherty N, Barnes J. Primary vaginismus: a psy-
chometric study of both partners. J Sex Marital Ther 1995;
10:9-22.
61. Lamont JA. Vaginismus. Am J Obstet Gynecol 1978;131:633-
636.
62. Mikhail AR. Treatment of vaginismus by i.v. diazepam
(Valium) abreaction interviews. Acta Psychiatr Scand 1976;
53:328-332.
63. Molaeinezhad M, Salehi M, Borg C, et al. Marriage consum-
mated for 32 Iranian women using therapist-aided exposure
therapy: a brief report. Sex Relat Ther 2014;29(3):293-306.
64. Muammar T, McWalter P, Alkhenizan A, et al. Management of
vaginal penetration phobia in Arab women: a retrospective
study. Ann Saudi Med 2015;35:120-126.
65. Munasinghe T, Goonaratna C, de Silva P. Couple characteristics
and outcome of therapy in vaginismus. Ceylon Med J 2004;
49:54-57.
66. O’Sullivan K. Observations on vaginismus in Irish women.
Arch Gen Psychiatry 1979;36:824-826.
67. O’Sullivan K, Barnes J. Vaginismus: a report on 46 couples. Ir
Med J 1978;71:143-146.
68. Pacik PT, Geletta S. Vaginismus treatment: clinical trials follow
up 241 patients. Sex Med 2017;5:e114-e123.
69. US National Library of Medicine. Identifier NCT01859507;
Injection of Botox in the perineal muscles in resistant cases of
vaginal spasm. Available at: https://clinicaltrials.gov/ct2/show/
NCT01859507. Accessed January 25, 2018.
70. Reamy K. The treatment of vaginismus by the gynecologist: an
eclectic approach. Obstet Gynecol 1982;59:58-62.
71. Reissing ED, Armstrong HL, Allen C. Pelvic floor physical
therapy for lifelong vaginismus: a retrospective chart review
and interview study. J Sex Marital Ther 2013;39:306-320.
72. Scholl GM. Prognostic variables in treating vaginismus. Obstet
Gynecol 1988;72:231-235.
73. Seo JT, Choe JH, Lee WS, et al. Efficacy of functional electrical
stimulation-biofeedback with sexual cognitive-behavioral
therapy as treatment of vaginismus. Urology 2005;66:77-81.
J Sex Med 2018;-:1e13
13
74. Shafik A, El-Sibai O. Vaginismus: results of treatment with
botulin toxin. J Obstet Gynaecol 2000;20:300-302.
75. ter Kuile MM, Bulté I, Weijenborg PT, et al. Therapist-aided
exposure for women with lifelong vaginismus: a replicated
single-case design. J Consult Clin Psychol 2009;77:149-159.
76. Yasan A, Akdeniz N. Treatment of lifelong vaginismus in
traditional Islamic couples: a prospective study. J Sex Med
2009;6:1054-1061.
77. ter Kuile MM, van Lankveld JJ, de Groot E, et al. Cognitive-
behavioral therapy for women with lifelong vaginismus: process
and prognostic factors. Behav Res Ther 2007;45:359-373.
78. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of
observational studies in epidemiology: a proposal for report-
ing. Meta-analysis of observational studies in epidemiology
(MOOSE) group. JAMA 2000;283:2008-2012.
79. Melles RJ, ter Kuile MM, Dewitte M, et al. Automatic and
deliberate affective associations with sexual stimuli in women
with vaginismus before and after therapist-aided exposure
treatment. J Sex Med 2014;11:786-799.
80. Reissing ED, Binik YM, Khalifé S. Does vaginismus exist? A
critical review of the literature. J Nerv Ment Dis 1999;
187:261-274.
81. Reissing ED. Consultation and treatment history and causal
attributions in an online sample of women with lifelong and
acquired vaginismus. J Sex Med 2012;9:251-258.
82. Rahman S. Female sexual dysfunction among Muslim women:
increasing awareness to improve overall evaluation and
treatment. Sex Med Rev 2018;6:535-547.
83. Molaeinezhad M, Khoei EM, Salehi M, et al. Validation of the
partner version of the multidimensional vaginal penetration
disorder questionnaire: a tool for clinical assessment of lifelong
vaginismus in a sample of Iranian population. J Educ Health
Promot 2014;3:114.
84. Bradford A. Listening to placebo in clinical trials for female
sexual dysfunction. J Sex Med 2013;10:451-459.
85. Bodenmann G. Dyadic coping and the significance of this
concept for prevention and therapy. Zeitschrift für Gesund-
heitpsychologie 2008;16:108-111.
86. Derogatis LR, Rosen R, Leiblum S, et al. The Female Sexual
Distress Scale (FSDS): initial validation of a standardized scale
for assessment of sexually related personal distress in women.
J Sex Marital Ther 2002;28:317-330.
87. Rosen R, Brown C, Heiman J, et al. The Female Sexual
Function Index (FSFI): a multidimensional self-report instru-
ment for the assessment of female sexual function. J Sex
Marital Ther 2000;26:191-208.
88. Arrindell WA, Emmelkamp P, Bast S. The Maudsley Marital
Questionnaire (MMQ): A further step towards its validation.
Personality and Individual Differences 1983;4:457-464.
SUPPLEMENTARY DATA
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.jsxm.2018.10.003.