International Urogynecology Journal

https://doi.org/10.1007/s00192-018-3586-6

ORIGINAL ARTICLE

Effectiveness of a continuous-use ring-shaped vaginal pessary

without support for advanced pelvic organ prolapse
in postmenopausal women
José Luis Dueñas 1,2 & Alessio Miceli 1

Received: 23 November 2017 / Accepted: 29 January 2018

# The International Urogynecological Association 2018

Abstract
Introduction and hypothesis There is considerable variation in the clinical management of pessaries. This study was aimed at
exploring the efficacy of the continuous use of ring pessaries without support for the treatment of advanced pelvic organ prolapse
(POP) in nonhysterectomized postmenopausal women.
Methods We conducted this prospective study of fitted pessaries between January 2013 and June 2015 in the Department of
Obstetrics and Gynecology at Macarena Hospital, Seville University, Spain. A total of 171 nonhysterectomized postmenopausal
patients with symptomatic POP (stages III and IV) were counseled for two treatment options: either surgery or vaginal pessary. A
total of 94 patients who agreed to use the vaginal ring pessary were included. A successful fitting was defined as the continued
use of the device until the end of the study (a median 27-month follow-up). The data were analyzed with continuity correction
tests, Mann–Whitney U tests, and Fisher’s exact test.
Results Pessary use was continued by 80.8% of the patients. Most discontinuations (50.0%) occurred within the first week after device
insertion. The adverse events rate was 31.6%, and all adverse events were Clavien–Dindo grade I. The complications were extrusion of
the pessary (18.4%), bleeding or excoriation (10.5%), and pain or vaginal discharge (2.6%). No major complications occurred.
Conclusions The ring pessary without support was successfully fitted in patients with advanced POP, resulting in a high success
rate. There were few side effects and complications associated with continuous use of this pessary without periodic removal or
replacement.

Keywords Advanced pelvic organ prolapse . Adverse events . Efficacy . Continuous use . Ring pessary without support

Introduction USA [2]. Conversely, pessaries are not commonly offered

Pelvic organ prolapse (POP) is a chronic pelvic floor dysfunc-
tion with a high prevalence among aging women, and its
prevalence increases with age [1]. Treatment options include
vaginal pessaries, pelvic floor muscle training, and surgery.
Pessaries are considered a first-line treatment option in the
* José Luis Dueñas
jlduenas@us.es
1
Department of Obstetrics and Gynecology, Hospital Universitario
Virgen Macarena, School of Medicine, Seville University,
Seville, Spain
2 el as the most frequently used device in the reviewed studies.
Department of Surgery, Obstetrics and Gynecology Area, School of
Medicine, Seville University, Avda. Dr. Fedriani, s/n 41009,
Seville, Spain
by gynecologists in Spain. There is a wide variation in the
efficacy rates of pessary use among different populations
worldwide and even within individual countries [3].
Generally, ring or other support pessaries are recommended
for patients with symptomatic POP quantification (POP-Q)
stage I/II [4], whereas space-filling pessaries, such as the
Gellhorn, are useful for women with more advanced prolapse
and less perineal support because they sometimes stay in place
whereas ring pessaries do not [5]. A study has recently been
published in which, contrary to the classic concept, the ring
pessary with support was successfully used to treat advanced
POP [6].
A recent systematic review identified the ring pessary mod-
The ring model is more widely used because it is easier to
insert and has better acceptance because it fits better into the

vagina. This model allows sexual activity without device re-
moval and has the fewest complications, as described in the
literature [7]. Prospective studies documenting complications
by shape, material, size, and objective classification of sever-
ity are required [8].
There is considerable variation in practice among clinicians
regarding pessary management. A survey of members of the
American Urogynecologic Society concluded that randomized
controlled trials are needed to define optimal pessary use [9].
Self-care is usually recommended to patients to manage the
pessary, either by themselves or with their caregivers, and to
remove and replace ring pessaries at frequent intervals; this
places control of the pessary in the patient’s hands, allowing
her to use it as needed. The goal of changing the pessary is to
prevent vaginal irritation, which leads to discharge, infection,
and erosion [5, 10]. In our practice, many patients are unable or
unwilling to manage pessary care themselves; thus, in this
study, we decided to not periodically remove or replace the
pessary. The hypothesis of the study was as follows: The con-
tinuous use of a ring pessary (without support) is effective in
nonhysterectomized postmenopausal Spanish women with ad-
vanced stages of POP-Q for medium-term use.
Materials and methods
Study participants
At the Department of Obstetrics and Gynecology, Macarena
Hospital, Medical School, Seville University, Spain, between
January 2013 and June 2015, a total of 171 nonhysterectomized
postmenopausal patients with symptomatic POP (stages III and
IV) were counseled regarding two treatment options: either
surgery or vaginal pessary. The inclusion criteria were
nonhysterectomized postmenopausal patients with symptomat-
ic POP (stages III and IV) who agreed to use the vaginal ring
pessary as treatment. Women who had mental illness or who
refused to participate in this study were excluded. A total of 94
patients (age range 47–90) who agreed to use the vaginal ring
pessary were included. All women were followed for a mini-
mum of 18 months (range, 18–49 months) after the start of their
pessary use. This study was approved by the Ethics Committee
of the Hospital Virgen Macarena (number 1168-N-17).
Study design
We recorded detailed information regarding the patients, in-
cluding age, parity, body mass index, sexual status, medical
co-morbidities, constipation, chronic cough, smoking status,
and prolapse symptoms, and we performed physical examina-
tions. Regarding urinary symptoms, the women were asked
the following questions at baseline: do you leak urine when
you cough, laugh, sneeze, or exercise? Do you leak urine
Int Urogynecol J
when you have the urge to empty your bladder? Do you have
to strain to empty your bladder or have difficulty emptying
your bladder? Do you need to insert your fingers into your
vagina (splint) to void urine? For data analysis, replies of
Bnever^ or Brarely^ were recorded as Bno,^ whereas replies
of Bsometimes,^ Busually,^ or Balways^ were recorded as
Byes.^ All patients were staged according to the Pelvic
Organ Prolapse Quantification system (POP-Q) by a single
experienced gynecologist [11]. The vaginal introitus size
was also measured, with the patients at rest, as the number
of horizontal fingerbreadths accommodated across the poste-
rior fourchette [6]. We decided to use only the ring pessary
without support instead of other types of pessaries because the
use of a single type reduces any potential bias, and there is no
evidence showing that any particular type of pessary is supe-
rior to another [10]. The same physician chose the ring pessary
size, and all pessaries were made of silicone (Corysan,
Barcelona, Spain). The ring pessary diameter varied from 50
to 100 mm, with 11 different sizes (size increments of 5 mm).
A pessary was considered to be the correct size when the
physician could place a single finger between the pessary and
the vaginal wall, the prolapse was reduced to above the hy-
men, it felt comfortable to the patient, and it was retained
during a Valsalva maneuver and while coughing when the
patient was in the supine and standing positions. We instructed
the patients on how to prevent expulsion during defecation.
We also taught the patient to palpate the pessary and hold it in
place during Valsalva or, alternatively, by squeezing her labia,
thereby closing the vaginal outlet. A topical estrogen cream
(10 mg/g promestriene cream, 0.5 g each time, twice a week)
was regularly prescribed to the patients, without contraindica-
tions. The follow-up schedule post-pessary insertion was at
1 week, at 4 weeks, and every 6 months thereafter if there
were no complications. The follow-ups were always conduct-
ed by the same physician who chose the ring pessary size.
In Spain, many patients may be unwilling or unable to man-
age pessary care themselves. Therefore, in this study, we ad-
vised not to periodically self-remove or self-replace the pessa-
ry. For this reason, all patients were monitored monthly at first
and then every 6 months. Speculum and bimanual pelvic ex-
aminations were performed without removing the pessary at
every visit to detect vaginal discharge, vaginal bleeding, or
vaginal erosion; to assess whether the pessary was adequately
relieving the patients’ symptoms; and to review pessary main-
tenance. At these visits, the pessary was not removed, rinsed or
replaced if there were no adverse events. The patients were
counseled to call us if vaginal odor, discharge, or bleeding
occurred because these symptoms would warrant investigation
for infection or erosion. A telephone hotline number was given
to all patients of this study for early consultation if needed.
After 1 week, an appointment was scheduled to evaluate
the fit. If the pessary fell out or if the patients experienced
discomfort within the first week, they were refitted with a
Int Urogynecol J
different sized ring pessary and were reviewed again after
another week. A maximum of three attempts was made to
achieve successful pessary fitting. A successful fitting was
defined as a patient who continued the pessary use until the
end of the study or a patient who had a pessary expulsion and
was refitted with a new pessary and continued its use. Adverse
events were evaluated in patients with successful fittings. In
women who experienced an increase in vaginal discharge or
bleeding, a speculum examination was carried out without
removing the pessary to look for erosions or abrasions. If
erosions were present, the pessary was removed for 2 weeks,
and local daily estrogen was advised. Other causes of post-
menopausal bleeding were investigated with vaginal ultra-
sound. If the vaginal pessary slipped out, the women were
offered a reassessment and replacement of the vaginal pessary.
If a vaginal pessary could not be fitted, conservative manage-
ment or surgery was discussed accordingly. Patients who
discontinued the pessary within the study period and were
unable to be refitted were categorized as having an unsuccess-
ful fitting. According to the study design, patients lost to
follow-up were defined as discontinuations; however, in this
study, no patients were lost to follow-up.
The success rate of ring pessary use and the incidence of
adverse events were evaluated. Our primary outcome included
the discontinuation of pessary use and the reasons for discon-
tinuation. Secondary outcomes included the presence of in-
creased vaginal discharge and the development of erosions
and vaginal bleeding. Increased vaginal discharge was defined
as either patient reports of an increase in vaginal discharge or
findings of moderate leukorrhea upon physical examination or
diagnosis of vaginitis or leukorrhea during a medical visit. In
this study, we categorized complication severity according to
a standardized severity scale, the Clavien–Dindo classification
[12]. A recent study documented that all five Clavien–Dindo
grades of surgical complications have occurred as a conse-
quence of pessary use [8].
Statistical analyses
Descriptive statistics were used for the demographic data. We
calculated the mean and standard deviation for continuous
variables. Continuity correction tests, Mann–Whitney U tests,
and Fisher’s exact test were used to compare categorical var-
iables as appropriate. A p value of <0.05 was considered to be
statistically significant. SPSS v.23.0 (IBM España SA,
Madrid, Spain) was used to perform the statistical analyses.
Results
A total of 171 advanced pelvic organ prolapse (POP) patients
(stages III and IV) were identified between January 2013 and
June 2015. A total of 94 (54.0%) women decided to use the
ring pessary, and 77 (45.0%) underwent surgical intervention.
The median patient age was 67 years (range, 47–90 years),
and the median parity was 3.6 (range, 1–8). All patients were
postmenopausal, and none had undergone previous hormonal
treatment. The median age at menopause was 50 years (range,
36–60 years). Nearly all patients (91 out of 94 [96.8%]) had
concomitant medical diseases, such as cardiovascular diseases
and/or rheumatological diseases. Fourteen patients (14 out of
94 [14.9%]) had a previous history of surgery for incontinence
with anterior vaginal mesh implantation. Fifty (50 out of 94
[53.2%]) patients were sexually active. The median genital
hiatus (GH) was 5.23 cm. The median total vaginal length
(TVL) was 8.38 cm, resulting in a GH to TVL ratio of 0.62.
Fifty-eight (58 out of 94 [61.7%]) patients had stage III
POP, and the remaining patients 36/94 (38.3%)] had stage IV
POP. Eight different sizes of ring pessaries (60, 65, 70, 75, 80,
85, 90 and 95 mm) were used for successful pessary fittings in
this study. The proportion of patients who utilized a size
75 mm (39 out of 94 [41.5%]), size 80 mm (19 out of 94
[20.2%]) or size 85 mm (16 out of 94 [17.0%]) ring pessary
was greater than those for patients using the other sizes. The
median follow-up time was 24 months (range, 18–49 months).
The ring pessary was fitted in 94 patients at the initial visit.
Pessary use was continued by 87 (87 out of 94 [92.6%]) pa-
tients during the first week, 85 (85 out of 94 [90.4%]) patients
at 1 month, 82 (82 out of 94 [87.2%]) at 6 months, 80 (80 out
of 94 [85.1%]) at 12 months and 76 (76 out of 94 [80.8%]) at
the end of the study. Four patients died from non-pessary-
related causes throughout the study (stroke 2, pneumonia 1,
and aortic thrombosis 1). Among the remaining 14 patients
who discontinued pessary use, the following reasons were cit-
ed for ceasing pessary use: feelings of discomfort 9, extrusion
of the pessary during daily activities3, bleeding 1, and dislike
of the ring pessary by the husband 1. After discontinuing pes-
sary use, these patients all opted for surgery. Most discontinu-
ations (7 out of 14 [50.0%]) occurred within the first week after
device insertion.
Thirteen (13 out of 94 [13.8%]) patients who presented ex-
trusion of the pessary during daily activities in the first week
opted for reinsertion. Nine (9 out of 94 [9.6%]) patients switched
to larger pessaries, 1 (1 out of 94 [1.1%]) switched to a smaller
pessary, and 3 (3 out of 94 [3.2%]) opted for a pessary of the
same size. However, a higher continuation rate (76 out of 94
[80.8%]) was observed among the patients with successful fit-
tings (94 patients; Fig. 1). When we excluded the deceased
patients, the continuation rate was 84.4% (76 out of 90).
At baseline, the three most common prolapse symptoms
were bulging (94 out of 94 [100.0%]), pelvic pressure (91
out of 94 [96.8%]), and bleeding (63 out of 94 [67.0%]).
Each woman had at least two of these symptoms. All prolapse
symptoms improved significantly after 1 month of pessary
use; in particular, bulging improved, with the incidence
 Int Urogynecol J

Assessed for eligibility

(n=171) However, all patients reported a mild degree of SUI, which
could be managed by pelvic floor muscle exercises.
Chose ring pessary Chose surgery Tables 1 and 2 show the patient clinical characteristics and
n=94 n=77 the results from the univariate analysis of patient characteris-
tics, including pelvic examination results, with the outcome of
At one week. None lost to follow-up ring pessary use. There was no association among age at re-
-Did well on pessary: 62
-Failed to retain pessary: 15
cruitment, menopause, body mass index, gravidity, number of
+Reinserted: 13 vaginal deliveries, history of previous largest babies, sexual
+Refused reinsertion: 2 (1 constipation, 1 requested surgery)
-Discomfort: 17 activity, medical comorbidities, chronic constipation, previous
+Requested pessary removal: 5 incontinence surgery, de novo SUI, and the ability to be fitted
CONTINUED USE: 87 [87/94 (92,6 %)] with a pessary (p > 0.05). In addition, no relationship among
TVL, GH size or pessary fitting was found (p > 0.05). There
At one month. None lost to follow-up
-Did well on pessary: 73 were no significant differences in the stage of prolapse in the
-Failed to retain pessary: 7 apical, anterior or posterior compartments and the most affect-
+Reinserted: 6
+Refused reinsertion and requested surgery: 1 ed prolapse compartment between the patients who were suc-
-Discomfort: 5 cessfully fitted with a pessary and those who failed to be fitted
+Requested pessary removal and surgery: 1
-Vaginal bleeding: 2 with a pessary.
CONTINUED USE: 85 [85/94 (90,4 %)]
Adverse events were evaluated in the patients with success-
ful fittings at the end of the study. The most common adverse
At six months. None lost to follow-up event was extrusion of the pessary during defecation or daily
-Death from aortic thrombosis: 1
-Did well on pessary: 82 activities, and this event was reported by 14 women (14 out of
-Failed to retain pessary: 1
+Reinserted: 1
76 [18.4%]). Bleeding or excoriation was observed in 8 pa-
-Discomfort: 2 tients (8 out of 76 [10.5%]). Pain or vaginal discharge was
+Requested pessary removal and surgery: 2
-Increased vaginal discharge: 2 reported by two women (2 out of 76 [2.6%]). All adverse
events in that group of patients (24 out of 76 [31.6%]) were
CONTINUED USE: 82 [82/94 (87.2 %)]
At twelve months. None lost to follow-up of Clavien–Dindo grade I, and there was a significant differ-
-Death from stroke: 1 ence between the group of women who had successful fittings
-Did well on pessary: 80
-Vaginal bleeding: 3 (24 out of 76 [31.6%]) and the group of women with unsuc-
+ Requested pessary removal and surgery: 1 cessful fittings (13 out of 14 [92.9%]; p < 0.05). In the present
-Vaginal erosion: 2
CONTINUED USE: 80 [80/94 (85.1 %)] study, none of the women presented major complications. The
mean (± standard error, SE) durations of pessary use among
At the end of study (Analyzed n=94). (Range, follow-up 18-49 months)
-Death from other unrelated causes: 4 (2 stroke, 1 pneumonia, 1 aortic thrombosis) patients with successful and unsuccessful fittings were 27.6 ±
-Failed to retain pessary. Refused reinsertion and requested surgery: 3 9.6 months and 6.0 ± 10.9 months respectively.
-Discomfort. Requested pessary removal and surgery: 9
-Bleeding. Requested pessary removal and surgery: 1
-Other causes: 1 (the ring pessary was not liked by her husband)

CONTINUED USE: 76 [76/94 (80,8 %)] Discussion

Fig. 1 The number of patients who continued ring pessary use and the
reasons for discontinuation
decreasing from 94 out of 94 (100.0%) to 14 out of 94
(14.9%). The percentage of patients experiencing pelvic pres-
sure decreased from 96.8% to 23.4%, and bleeding decreased
from 67.0% to 2.1%. Regarding urinary symptoms at base-
line, 55.3% (52 out of 94) of the patients reported voiding
difficulty, 46.8% (44 out of 94) reported urge urinary inconti-
nence, and 37.2% (35 out of 94) reported stress urinary incon-
tinence (SUI). All urinary symptoms improved after 1 month
of pessary use. Voiding difficulty improved in 92.3% (48 out
of 52) of the patients, urge urinary incontinence improved in
75.0% (33 out of 44), and SUI improved in 77.1% (27 out of
35). Among the 59 patients with no preexisting SUI, after
1 month, 9 (9 out of 59 [15.3%]) developed new-onset SUI.
Successful use of a pessary depends on many factors, which
include finding an appropriate pessary type, the size at the
fitting, and encouraging regular communication and follow-
up [13]. Currently, not enough evidence is available in the
literature to prove that one type of pessary is superior to an-
other. A Cochrane review has identified only one randomized
controlled trial comparing ring pessaries (with support) to
Gellhorn pessaries, and that trial found no statistically signif-
icant difference in the symptom scores between the two pes-
saries and suggested that new randomized controlled trials
might be required [14].
Several studies have evaluated the success of pessary
fitting, with success rates ranging from 41% to 74% [4].
Success rates of up to 62% have been reported in 32 patients
with stage III and IV POP. The types of pessaries used includ-
ed Gellhorn, ring, and donut [15]. In 2011, Manchana reported
Int Urogynecol J

Table 1 Patient characteristics in

the successful and unsuccessful Characteristic Successful (n = 76) Unsuccessful (n = 14) p value
pessary fitting groups
Mean age, years, ± SD 67.7 ± 8.6 65.6 ± 6.9 0.384*
Mean age of menopause, y ears, ± SD 50.2 ± 3.8 50.6 ± 5.0 0.757**
Mean gravidity ±SD 3.7 ± 1.5 3.6 ± 1.6 0.823**
Mean vaginal deliveries ±SD 3.3 ± 1.3 3.4 ± 1.3 0.881**
BMI > 25 kg/m2, n (%) 20 (26.3) 4 (28.6) 0.861***
Largest baby ≥4 kg, n (%) 42 (55.3) 8 (57.1) 0.897***
Sexually active, n (%) 41 (53.9) 9 (64.3) 0.474***
Medical comorbidities, n (%) 74 (97.4) 13 (92.9) 0.402****
Diabetes, n (%) 16 (21.0) 3 (21.4) 0.975***
Cardiovascular diseases, n (%) 50 (65.8) 8 (57.1) 0.535***
History of breast cancer, ovary, and/or 4 (5.3) 0 (0.0) 1****
bowel cancer, n (%)
Tamoxifen therapy, n (%) 4 (5.3) 0 (0.0) 1****
Rheumatological diseases, n (%) 50 (65.8) 11 (78.6) 0.347***
Lumbar disc herniation, n (%) 17 (22.4) 3 (21.4) 0.938***
Anticoagulation therapy, n (%) 14 (18.4) 0 (0.0) 0.081***
Caregiver, n (%) 34 (44.7) 7 (50.0) 0.715***
History of heavy job (%) 42 (55.3) 4 (28.6) 0.066***
Smoking, n (%) 6 (7.9) 1 (7.1) 0.923***
Chronic cough, n (%) 7 (9.2) 0 (0.0) 0.237***
Chronic constipation, n (%) 47 (61.8) 12 (85.7) 0.084***
Prior abdominal surgery, n (%) 17 (22.4) 3 (21.4) 0.938***
Prior incontinence surgery, n (%) 12 (15.8) 2 (14.3) 0.887***
History of urinary urge
Incontinence, n (%) 34 (44.7) 9 (64.3) 0.178***
History of urinary stress
Incontinence, n (%) 28 (36.8) 5 (35.7) 0.936***
De novo stress incontinence, n (%) 7 (9,2) 3 (21.4) 0.181***
Total vaginal length, cm ± SD 8.4 ± 0.7 8.2 ± 0.4 0.112**
Genital hiatus, cm ± SD 5.4 ± 1.0 4.7 ± 1.2 0.05**

SD standard deviation, BMI body mass index

*Independent sample t test
**Mann–Whitney U test
***Continuity correction Chi-squared test
****Fisher’s exact test

a successful use of ring pessary for symptomatic POP patients,
71% of whom had POP-Q stage III/IV. The success rate in that
study was 52% at the 13-month median follow-up [10]. In the
present prospective cohort study, 94 women with symptomat-
ic advanced stage POP were successfully fitted with a ring
(without support) pessary at the initial visit, and 76 patients
(76 out of 94) continued to use the pessary at the end of the
study (at the 27-month median follow-up), resulting in a suc-
cess rate of 80.8%. The ring pessary used by Manchana [10]
differed from that used by us. Their ring only comes in five
different sizes, whereas the one used by us comes in 11 sizes,
and this probably allowed us to achieve a more precise and
effective adjustment in our patients. On the other hand,
Manchana recommended removing the pessary at least once
weekly, probably increasing some adverse effects, such as
bleeding. Although ring pessaries are recommended for pa-
tients with symptomatic POP-Q stage I/II [5], our results sug-
gested that they could also be used to treat advanced stages of
POP. We prescribed all patients vaginal estrogen cream to
maintain a healthy vaginal epithelium and to prevent erosion.
In addition, in this study, the ring pessary without support was
not periodically removed or replaced, a procedure that has the
benefits of convenience and comfort, especially in patients
who are unable or unwilling to manage pessary care them-
selves. These reasons may have contributed to our high suc-
cess and elevated continuation rates.
 Int Urogynecol J

Table 2 Prolapse severity and predominant location of support loss [1.1%]), and dislike of the pessary by the patient’s husband
with successful and unsuccessful pessary usage
(1 out of 94 [1.1%]). After discontinuing pessary use, these
Successful Unsuccessful p value patients all opted for surgery.
(n = 76) (n = 14) The clinical predictors of successful and unsuccessful fit-
tings and the reasons for early discontinuation are unclear. It
Stage of apical prolapse, n (%) 0.989*
has been suggested by other authors that a previous hysterec-
Stage III 61 (80.3) 11 (78.6)
tomy narrows the upper vaginal diameter, making it difficult
Stage IV 10 (13.1) 2 (14.3)
to retain a pessary [13]. In our study, none of the patients had
Stage of anterior prolapse, n (%) 0.747*
previously undergone a hysterectomy because the study was
Stage III 39 (51.3) 6 (42.8)
designed only to explore the efficacy of the continuous use of
Stage IV 1 (1.3) 0 (0.0) ring pessary in nonhysterectomized postmenopausal women.
Stage of posterior prolapse, n (%) 0.175* However, in our clinical practice, we offer hysterectomized
Stage III 9 (11.8) 0 (0.0) women with POP both surgery and conservative treatment.
Stage IV 0 (0.0) 0 (0.0) Currently, we are conducting a similar study in hysterecto-
Predominant compartment of 0.44** mized patients. One multicenter study has reported that the
support loss, n (%)
Anterior wall 6 (7.9) 2 (14.3)
average vaginal length of patients who are successfully fitted
Apex 70 (92.1) 12 (85.7)
with a pessary is 9.6 cm [18]. We found that the average
Posterior wall 0 (0.0) 0 (0.0)
vaginal length of the patients with successful fittings was
8.4 cm and that there was no difference in vaginal length
*Fisher’s exact test between patients with successful and failed fittings. The rea-
**Continuity correction Chi-squared test sons for failure in our study were more subjective (discomfort
or Bthe pessary was not liked by her husband^) than objective
(the pessary fell out, or bleeding occurred).
An important problem with pessary use is the long-term Several studies have evaluated the complications of suc-
continuation rate [10]. Several studies have reported the high cessfully fitted ring pessaries, with rates ranging from 56 to
effectiveness of short-term pessary use. However, the study 58% [16, 19]. These authors reported the overall complica-
with the longest follow-up (over a 6- to 15-year-period) re- tions, which included pessary extrusion (28%), bleeding (6.8
ported that only 14% of their patients continued pessary use at to 47%), and vaginal discharge (26%). In our study, the ad-
the 7-year-median follow-up [16]. Factors associated with verse events rate was lower (31.6% [24 out of 76]). The most
pessary use for more than 1 year include age older than 65, common adverse event was extrusion of the pessary during
severe comorbidity, and maintenance of urinary continence defecation or daily activities, which was reported by 18.4% of
[17]. The median age of the ring pessary users in our study the women (14/76). Bleeding or excoriation was observed in
was 67 years, and all patients in this study selected pessary use 10.5% (8 out of 76), and pain or vaginal discharge was report-
from two treatment options, which may have contributed to ed by 2.6% (2 out of 76) of the patients. We think that the
the high continuation rate (80.8%) at the 27-month median superior results obtained in our study are primarily due to the
follow-up. One strength of this study is that a ring pessary absence of periodic self-manipulation of the pessary by our
was offered to all women with advanced POP, not just to patients, as periodic removal or replacement of pessaries by
women who were poor surgical candidates or who declined patients can increase the risk of infection or erosion of the
surgery; therefore, the results provide a more accurate estimate vaginal mucosa and produce greater rates of bleeding, discom-
of the effect of the pessary on advanced prolapse. However, fort, vaginal discharge, and extrusion of the pessary. Major
further studies with longer follow-up should be investigated. complications, such as impaction and urinary, rectal, and gen-
In a systematic review, the median discontinuation rate for ital complications, usually occur in neglected patients [17]. In
the seven reviewed studies was 49.1% (range, 37–80%). The the present study, none of the women developed serious ad-
rationales for discontinuation included failure to retain the verse events.
pessary, discomfort, a desire for surgery, and an inability to We categorized complication severity according to a stan-
remove insert/remove the pessary. This revision identified the dardized severity scale, the Clavien–Dindo classification [12].
ring pessary model as the most frequently used device in the This approach is based on the type of therapy used to correct a
studies, and this type is the pessary with the fewest complica- specific complication and is a form of classification that is
tions described in the literature [7]. In our study, pessary use increasingly used in surgical research to provide an objective
was discontinued by only 14.9% (14 out of 94) of patients, and reproducible ranking of the reporting of complication se-
and the reasons for ceasing pessary use were feelings of dis- verity. Hence, the extrapolation to pessary use is considered
comfort (9 out of 94 [9.6%]), extrusion of the pessary during justified because, similar to surgery, pessaries are a form of
daily activities (3 out of 94 [3.2%]), bleeding (1 out of 94 physical treatment, which makes this type of classification
Int Urogynecol J
more suitable than those used for pharmacological treatments.
A recent study has documented that all five Clavien–Dindo
complication grades occurred as a consequence of pessary use
[8]. In this study, all adverse events (24 out of 76 [31.6%])
were of Clavien–Dindo grade I. We think that the broad im-
plementation of this classification in the urogynecological lit-
erature may facilitate the evaluation and comparison of pessa-
ry results and surgical outcomes among different physicians,
centers, and therapies.
It has been proposed that wearing a vaginal ring pessary for
long periods [8] or not changing the pessary regularly [20]
may cause major complications. Traditionally, most pessaries
have been changed every 6 months, the rationale being to
prevent infection and fistulae; however, there is no evidence
regarding the expected incidence of those complications or
that regular changing of the pessary is preventative. The com-
plication rates did not vary greatly between the 3-month and
6-month changing intervals and even tended to decrease with
interval length up to the 12-month follow-up period [21]. Our
findings showed high success rates for the medium-term use
of a ring pessary, without severe complications, indicating that
a ring pessary without support could also be used without
periodic removal or replacement to treat advanced-stage
POP. In addition, this practice could have financial implica-
tions by reducing the economic costs associated with regular
pessary change.
A strength of this study is that it was a prospective study
performed to explore the efficacy of ring pessary use without
periodic removal or replacement for the treatment of
advanced-stage POP, and the results may provide useful infor-
mation for clinical practice. All patients in this study selected
pessary use out of two treatment options (pessary or surgery),
and the patients were always examined by only one senior
gynecologist; therefore, the measurements of POP-Q and vag-
inal introitus were consistently quantified. The study limita-
tions include the collection of the data from a single institution
and the limited sample size. Thus, additional prospective,
multicenter studies with large sample sizes are needed.
Validated questionnaires were not used to assess subjective
outcome. This study focused on the medium-term results of
pessary use, and a long-term follow-up should be investigated
in additional studies.
Conclusions
Our results suggest that a ring pessary without support can be
recommended as the first-line treatment in patients with ad-
vanced stages of POP for medium-term use. There are few
side effects and complications associated with continuous
use of this pessary without periodic removal or replacement
when patients are followed up properly.
Acknowledgements We thank all patients for agreeing to participate in
this study.
Compliance with ethical standards
Conflicts of interest None.
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