You are on page 1of 6

Female Urology

Changes in Prolapse and Urinary

Symptoms After Successful Fitting of
a Ring Pessary With Support in Women
With Advanced Pelvic Organ Prolapse:
A Prospective Study
Jing Ding, Chun Chen, Xiao-chen Song, Lei Zhang, Mou Deng, and Lan Zhu




To estimate the percentage of improvement in prolapse and urinary symptoms and adverse effects
in women with advanced pelvic organ prolapse (POP) after 3 months of use of a ring pessary with
In this prospective study, 109 consecutive women with advanced POP were tted with a ring
pessary with support; 73 (73/109, 67.0%) of the women had a successful 3-month pessary tting
trial. Prolapse symptoms, urinary symptoms, and urinary ow parameters were assessed at baseline
and at 3 months. Adverse effects were assessed within 3 months. McNemars test and pairedsample t tests were performed.
Prolapse and urinary symptoms improved from baseline to 3 months, including bulging (90.4% to
23.3%; P <.001) and pressure (64.4% to 13.7%; P <.001). Voiding difculty improved in 97.8%
of the women (45/46; P <.001), splinting improved in 100% (19/19; P <.001), urge urinary
incontinence improved in 76.9% (30/39; P <.001), and stress urinary incontinence improved in
58.1% (18/31; P .025) after 3 months. After pessary treatment, the differences in maximum
ow rate, mean ow rate, void volume, and postvoid residual at baseline and 3 months were
statistically signicant (P <.05). Vaginal discharge (32/73, 43.8%) was the most common adverse
event. Vaginal ulcers developed in 7 (7/73, 9.6%) of the women.
The ring pessary with support was successfully tted in patients with advanced POP with a high
success rate and few complications. The pessary could resolve more than half of the prolapse and
urinary symptoms. Therefore, initial conservative treatment with a ring pessary with support in
advanced POP is worthwhile. UROLOGY 87: 70e75, 2016.  2016 Published by Elsevier Inc.

elvic organ prolapse (POP) is a chronic pelvic oor

disorder that is highly prevalent among older
women.1,2 Treatment for POP includes surgical or
nonsurgical options. A survey conducted by the American Urogynecological Society showed that nearly twothirds of physicians would chose vaginal pessary rather
than surgery as the rst-line treatment.3 Pessaries can be
categorized into 2 types: support and space-occupying.
Ring pessaries and other support pessaries are mostly
recommended for stage I and II prolapse and have the

Financial Disclosure: The authors declare that they have no relevant nancial interests.
From the Departments of Obstetrics and Gynecology, Peking Union Medical College
Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Beijing, China
Address correspondence to: Lan Zhu, M.D., and Jing Ding, Ph.D., Departments of
Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union
Medical College, Chinese Academy of Medical Sciences, No.1 ShuaiFu Road, Dongcheng District, Beijing 100730, China. E-mail:;
Submitted: May 22, 2015, accepted (with revisions): July 20, 2015


2016 Published by Elsevier Inc.

benets of convenience and comfort.4-6 In contrast, the

Gellhorn and other types of space-occupying pessaries are
often used to treat advanced cases of prolapse.7 However,
the Gellhorn pessary is difcult for patients to remove and
reinsert. In clinical practice, we have found that the ring
pessary with support can be inserted successfully in patients with stage III or IV prolapse.
To date, studies of pessary use have focused primarily on
successful pessary tting and continuation rates,6,8,9 and a
validated questionnaire has been used to obtain subjective
data (changes in symptoms) from these women.10-12
However, data regarding symptomatic relief with pessary
use are limited. Our study is the rst to employ the innovative use of urinary ow measurements to objectively
evaluate changes in urinary symptoms. Our purpose was to
explore changes in prolapse symptoms, urinary symptoms,
urinary ow parameters, and adverse effects after 3 months
of pessary use among women with advanced POP who had
a successful ring pessary with support tting trial.


Study Participants
Patients with symptomatic POP (stages III and IV) who presented to the Center of Obstetrics and Gynecology of Peking
Union Medical College Hospital (PUMCH) in Beijing between
November 2013 and September 2014 were counseled regarding
treatment options. All of the patients chose pessary use from the
3 options that were offered, which also included expectant
therapy with pelvic oor muscle exercise and surgical treatment.
The study was approved by the ethics committee of PUMCH
(number: s-671).

Study Design
Baseline clinical data, information about medical history, and
physical examination ndings were recorded. POP was staged
according to the POP quantication system.13 All of the patients
were under the care of a single experienced urogynecologist.
The patients were asked to present to the center with a
comfortably full bladder and were asked to void in a private
setting into a gravimetric urinary owmeter (digital urodynamic
machine, solar silver, MMS International, the Netherlands).
Void volume (Vv) as well as the mean (Qmean) and maximum
(Qmax) ow rates were measured. The postvoid residual (PVR)
volume was measured by ultrasonography immediately after the
urinary ow assessment. Bladder volume (BV) was determined
as the Vv plus the PVR. All urinary ow measurements were
taken without reduction of the prolapse. A urinary ow study
was dened as abnormal if the Qmax was <15 mL/second, the
Qmean was <10 mL/second, or the PVR was >100 mL.14
Prolapse symptoms included vaginal bulging and pelvic pressure, and urinary symptoms included voiding difculty, a need
for splinting to void, stress urinary incontinence (SUI) and urge
urinary incontinence. The women were asked the following
questions regarding prolapse symptoms at baseline: (1) Do you
see or feel a bulge in your vagina? (2) Do you feel pelvic pressure? Similarly, regarding urinary symptoms, the women were
asked the following questions at baseline: (1) Do you leak urine
when you cough, laugh, sneeze, or exercise? (2) Do you leak
urine when you have the urge to empty your bladder? (3) Do
you have to strain to empty your bladder or have difculty
emptying your bladder? (4) Do you need to insert your ngers
into your vagina (splint) to void urine? For data analysis, replies
of never or rarely were recorded as no, whereas replies of
sometimes, usually, or always were recorded as yes.
We did not routinely prescribe vaginal estrogen (Ovestin
estriol cream) before pessary tting, unless the patient had
vaginal ulceration. The initial tting usually began with a ring
pessary with support (Cooper Surgical, Trumbull, CT), followed
by a Gellhorn. In general, the largest pessary that was
comfortable for the patient was used. In the event that a pessary
t comfortably, the patient was asked to ambulate and to
perform Valsalva maneuvers during the ofce visit. If the patient
felt comfortable with the pessary, she was taught how to manage
the pessary, which included removing, cleaning, and replacing
the pessary on a regular basis. All of the patients were advised to
remove and clean the pessary before going to bed and to reinsert
it the following morning at least once a week.7 On the same day,
the patients were prescribed topical estrogen cream to protect
the local vaginal mucosa from erosions. The type and size of the
vaginal pessary inserted were also recorded. The successfully
tted patients returned in 1 week for follow-up. Another visit
was then routinely scheduled at 4 weeks and 3 months after the
UROLOGY 87 (C), 2016

initial tting. At each visit, the patient was asked about symptoms such as vaginal bleeding, abnormal vaginal discharge, pain
or discomfort, and de novo urinary incontinence. At the 3month visit, the patient was asked about her prolapse and urinary symptoms. The women were asked the same questions
again, and their replies were coded the same way. A symptom
was resolved if the baseline reply was yes and the 3-month
reply was no. A symptom was persistent if the baseline
reply was yes and the 3-month reply was yes. A symptom was
de novo if the baseline reply was no and the 3-month reply
was yes. Urinary ow measurements were again taken, this
time with the pessary inserted.
In the case of ulceration or vaginal bleeding, a pessary-free
period of 2 weeks was recommended, and the patient was
advised to use topical estrogen cream. Thereafter, the pessary
was reinserted if the ulceration had healed. The patients who
discontinued pessary use could return to discuss surgical options
if desired. The number of tting attempts and the subjective
reasons for discontinuation were carefully recorded. Further
follow-up visits were scheduled on a 6-month basis.

Statistical Analyses
We calculated means and standard deviations for continuous
variables. Paired-sample t tests were used to compare continuous
variables between groups. McNemars test was used to compare
categorical variables as appropriate. A P value of .05 was
considered to be signicant. SPSS version 19.0 (IBM Corp,
Armonk, NY) was used to perform the statistical analyses.

One hundred nine patients with advanced POP agreed to
a trial pessary insertion. The ring pessary with support was
tted in 81 patients at the initial visit. Another 28 patients used the Gellhorn pessary. Therefore, we analyzed
the 81 patients who used the ring pessary with support.
Seventy-seven (70.6%, 77/109) patients continued pessary use at 1 week, whereas 76 (69.7%, 76/109) patients
continued at 1 month and 73 (67%, 73/109) patients
continued at 3 months. A total of 8 patients discontinued
pessary use at 3 months. Most of the failures (4/8, 50%)
occurred within 1 week after initial use of the device. The
reasons for discontinuing pessary use were as follows:
feelings of discomfort and pressure (n 3), a desire for
surgical treatment of the condition (n 3), extrusion of
the pessary during daily activities (n 1), and bothersome de novo SUI (n 1). After discontinuing pessary
use, half of these patients opted for surgery; in the other
half, the device was removed without further treatment.
We analyzed the characteristics of the 73 patients who
used the ring pessary with support for more than
3 months. The median patient age was 70 years (range,
47-85 years), and the median parity was 2 (range, 0-8).
The median body mass index was 24.61 kg/m2. The
median genital hiatus (GH) was 4.95 cm (range, 3-6 cm),
and the median total vaginal length (TVL) was 7.6 cm
(range, 5-10 cm), resulting in a GH/TVL of 0.65. All of
the patients were postmenopausal, and none had received
hormonal treatment. More than half of the patients
(40/73, 54.8%) had concomitant medical diseases such as

109 patients
Fitting trial
81 patients
Ring pessary with support

28 patients
1 week

77 patients continued

4 patients discontinued
1 month

76 patients continued

1 patient discontinued
3 months

73 patients

3 patients

Figure 1. Study owchart (the number of patients with advanced pelvic organ prolapse who continued and discontinued
pessary use).

Table 1. Changes in prolapse and urinary symptoms from

baseline to 3 months in women who were successfully
tted with a ring pessary with support

Size 1
Size 2

web 3C=FPO

Size 3


Size 4

3-mo Follow-up (n)

Voiding dysfunction
Vaginal splinting

Figure 2. The proportion of pessaries after 3 months. (Color

version available online.)

Urgency incontinence
Stress incontinence

diabetes mellitus and/or hypertension. Most (80.8%, 59/73)

of the patients could manage the pessary by themselves.
Only 1 patient (1/73, 1.4%) had a history of surgical
treatment for prolapse, with hysterectomy (Fig. 1).
Eight (8/73, 11.0%) patients had stage IV POP, and the
remaining patients (65/73, 89.0%) had stage III POP. Four
different sizes of ring pessaries with support (1, 2, 3, and 4)
were used for the successful pessary ttings in this study. The
proportion of patients who utilized a ring pessary with support of size 2 (26/73, 35.6%) or 3 (30/73, 41.1%) was higher
than the proportion that utilized the other sizes (Fig. 2).
At baseline, the 2 most common prolapse symptoms
were bulging (66/73, 90.4%) and pelvic pressure (47/73,
64.4%). Each woman had at least one of these symptoms.
Both prolapse symptoms improved signicantly with
pessary use, especially bulging, which decreased from a
prevalence of 66/73 (90.4%) patients to 17/73 (23.3%;
P <.001). After using the pessary, 49 patients could not




P Value





Statistical signicance (P <.05) (McNemars test).

feel a bulge, and another 17 patients could feel a slight

bulge when performing Valsalva maneuvers, but the bulge
did not affect their usual activities. The percentage of
patients experiencing pelvic pressure decreased from
64.4% to 13.7% (P <.001). Regarding urinary symptoms
at baseline, 63.0% (46/73) reported voiding difculty,
53.4% (39/73) reported urge urinary incontinence, and
42.5% (31/73) reported SUI. Splinting to void, which
occurred in 19/73 patients (26.0%), was less common.
More than half of the patients with urinary symptoms
experienced improvement from baseline to 3 months.
Voiding difculty improved in 97.8% (45/46; P <.001),
splinting improved in 100% (19/19; P <.001), urge urinary incontinence improved in 76.9% (30/39; P <.001),
and SUI improved in 58.1% (18/31; P .025) of the
patients, as shown in Table 1.
UROLOGY 87 (C), 2016

Table 2. Urinary ow measurement parameters at baseline and at 3 months in women who were successfully tted with a
ring pessary with support
Abnormal urinary ow
Parameters, n
Qmax, mL/s
Qmean, mL/s
Vv, mL
BV, mL



3-mo Follow-up



P Value

BV, bladder volume; PVR, postvoid residual; Qmax, maximum ow rate; Qmean, mean ow rate; Vv, void volume.
Statistical signicance (P <.05).
* McNemars test.
Paired-sample t test.

Total Vv was between 151.2 mL and 685.9 mL. Fortytwo women had abnormal urinary ow parameters; at
baseline, 12, 42, and 5 abnormal Qmax, Qmean, and
PVR values, respectively, were recorded. Each woman
had at least 1 abnormal urinary ow parameter. After
3 months of pessary treatment, the number of women
with abnormal urinary ow parameters were notably
reduced, from 42 to 18 (P <.001). There were signicant
differences in Qmax, Qmean, Vv, and PVR between
baseline and 3 months (P <.05). However, POP did not
inuence the storage function of the bladder (P >.05;
Table 2).
Vaginal discharge, which occurred in 32/73 patients
(43.8%), was the most common adverse event, followed
by uncomfortable sensations (14/73, 19.2%) and vaginal
erosions (7/73, 9.6%). Of the 42 patients with no prior
history of SUI, 6 (14.3%) developed new-onset SUI.
However, all of the patients reported a mild degree of SUI
that could be managed by pelvic oor muscle exercises.
De novo urge urinary incontinence was uncommon,
occurring in only 11.8% of the women (4/34). No other
complications were noted.

Resolution of Symptoms
A nonvalidated questionnaire was not used to obtain the
subjective data. Instead, we routinely asked these questions of our patients at baseline and follow-up to obtain
an honest assessment of their symptoms. Changes in
urethral and vaginal position in patients with POP affect
the bladder and the urethra. Therefore, physicians should
inquire not only about bulges or lumps in the vagina and
pelvic pressure but also about voiding difculty, whether
patients need to insert their ngers in the vagina to void,
urinary urgency, and urinary incontinence. In our study,
more than half of the prolapse and urinary symptoms
resolved. We also found that most of the SUI problems
resolved even without the use of an incontinence pessary.
This is because the ring pessary with support uses the
pelvic diaphragm as the basis for support and is designed
to exert a supportive effect on the anterior and apical
vaginal walls.17 Bhatia et al18 demonstrated an increase in
functional urethral length and urethral closure pressure in
patients who were treated with a pessary for stress incontinence. Therefore, it can also resolve the problem of


Urinary Flow Measurement Parameters

Urinary ow measurement is a noninvasive method that
reects detrusor contractility and urethral resistance. We
performed baseline urinary ow measurement tests
without reduction of the prolapse, because reduction may
relieve urinary symptoms and can inuence the evaluation of lower urinary tract function in patients with
POP.19 At 3 months, we performed repeat urinary ow
measurements without removal of the pessary in an
attempt to reect the patients actual situation.
Lower urinary tract symptoms are common in women
with genital prolapse. POP does not appear to adversely
affect bladder capacity but does affect voiding function.
Concurrent voiding difculty and prolapse were evaluated by Romanzi et al,20 who studied 60 women with
various grades of cystocele. They found 25 women with
grade 3 or 4 cystocele, and 18 of the women (72%) had
urethral obstruction on urodynamic evaluation. After
pessary insertion, 17 of the women (94%) experienced
resolution of their obstruction. This nding is similar to

The ring pessary with support is the common type of

pessary, and it can be inserted successfully in patients with
advanced-stage POP. Although pessary use is theoretically recommended only for patients with early-stage
POP, in our study, 67% of 109 consecutive women
with symptomatic stage III or IV POP were successfully
tted with a ring pessary with support at 3 months. Three
other studies have evaluated pessary tting, and the reported successful tting rates ranged from 56% to
64%,8,15,16 which is slightly lower than the 67% rate
observed in the present study. The failure rate was less
than 10% (8/81) at 3 months. A higher continuation rate
(73/81 [90.1%]) was achieved among the patients with
successful ttings (81patients). These ndings will be
valuable to clinicians deciding which type of pessary to
order for a gynecologic patient. The ring pessary with
support is easy to utilize and remove; thus, it is typically
used for the initial tting in patients with POP at any
UROLOGY 87 (C), 2016


our results. In our study, we found signicant differences

in Qmax, Qmean, Vv, and PVR between the baseline
and 3-month visits (P <.05), supporting the hypothesis
that the urethra is functionally obstructed in the
advanced stages of prolapse. The objective data suggested
that the ring pessary with support could resolve the mechanical obstruction of the nonmobile urethra caused by
the advanced POP.
Some authors have reported that urethral catheterization does not provide as accurate a measure of PVR
volume as is generally perceived.21 This can result from
the use of a surplus length of catheter and positioning of
the eyelets far from the bladder neck, which may result in
incomplete emptying. Although urethral catheterization
has been accepted as the gold standard for PVR measurements, this method may cause discomfort for patients
and carries a risk of urinary tract infection and trauma. To
overcome these limitations, noninvasive ultrasound BV
measurements have been used as an alternative to urethral catheterization.22 Yong Hyun Parks results showed
that BV measurements obtained with portable ultrasound
devices correlate very well with the actual volume.23
Adverse Effects
Adverse events were evaluated in 73 of the patients who
underwent successful pessary tting. Vaginal erosions
were detected in 7 of the 73 patients (9.6%), all of whom
were treated with topical estrogen and temporary pessary
removal. However, adverse events usually occur only in
patients who have poor follow-up care.24 Therefore,
regular follow-up is needed in all patients who manage
the pessary themselves. Occult SUI, with rates ranging
from 36% to 72%, has been reported by several authors,25,26 but only 14.3% of the women with occult stress
incontinence in our study exhibited symptoms. This rate
may have been lower in our study because of the possible
therapeutic benet of the ring pessary with support. Major
complications, such as impaction and urinary, rectal, and
genital complications, can occur because of neglect24 (ie,
not changing the pessary regularly). In the present study,
none of the women developed major complications.
One strength of this study is that it is the rst report of
changes in subjective and objective symptoms in women
who were successfully tted with a ring pessary with
support for advanced POP. We routinely asked these
questions of our patients at baseline and follow-up to
obtain an honest assessment of their symptoms. Another
strength of this study is that a pessary was offered to all
women with symptomatic POP, not just to women who
were poor surgical candidates or who declined surgery;
therefore, the results provide a more accurate estimate of
the effect of the pessary on prolapse and urinary
The study was limited by the fact that other urinary
symptoms, such as hesitation, weak stream, and stop-start
voiding, which can predict voiding impairment,27 were
not investigated. We did not record comorbidities,
excluding diabetes mellitus and hypertension. The

women were assessed only at 3 months, so long-term results have not been established. We will continue followup visits for 1 year in the 73 women who continued using
the pessary at 3 months.

Nearly 67% of women with advanced POP can be treated
with a ring pessary with support for more than 3 months;
their symptoms improved, even if they did not completely
resolve. The ring pessary with support is a simple and
effective treatment for advanced POP.
Acknowledgments. We thank all of the patients for agreeing
to participate in our study.
Dr. Jing Ding is a Ph.D. candidate who was trained at the
Peking Union Medical College Hospital, Beijing, China. I
would like to thank Dr. Xin-wen Shi for performing the urinary
ow measurement tests.

1. DeLancey JO. The hidden epidemic of pelvic oor dysfunction:
achievable goals for improved prevention and treatment. Am J
Obstet Gynecol. 2005;192:1488-1495.
2. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic
pelvic oor disorders in US women. JAMA. 2008;300:1311-1316.
3. Cundiff GW, Weidner AC, Visco AG, et al. A survey of pessary use
by members of the American urogynecologic society. Obstet Gynecol. 2000;95:931-935.
4. Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and
urinary incontinence. Rev Obstet Gynecol. 2010;3:3-9.
5. Manchana T. Ring pessary for all pelvic organ prolapse. Arch
Gynecol Obstet. 2011;284:391-395.
6. Clemons JL, Aguilar VC, Tillinghast TA, et al. Risk factors associated with an unsuccessful pessary tting trial in women with pelvic
organ prolapse. Am J Obstet Gynecol. 2004;190:345-350.
7. Weber AM, Richter HE. Pelvic organ prolapse. Obstet Gynecol.
8. Sulak PJ, Kuehl TJ, Shull BL. Vaginal pessaries and their use in
pelvic relaxation. J Reprod Med. 1993;38:919-923.
9. Markle D, Skoczylas L, Goldsmith C, Noblett K. Patient characteristics associated with a successful pessary tting. Female Pelvic Med
Reconstr Surg. 2011;17:249-252.
10. Brazell HD, Patel M, OSullivan DM, et al. The impact of pessary
use on bowel symptoms: one-year outcomes. Female Pelvic Med
Reconstr Surg. 2014;20:95-98.
11. Cundiff GW, Amundsen CL, Bent AE, et al. The PESSRI study:
symptom relief outcomes of a randomized crossover trial of the ring
and Gellhorn pessaries. Am J Obstet Gynecol. 2007;196:405.e1-405.
12. Komesu YM, Rogers RG, Rode MA, et al. Pelvic oor symptom
changes in pessary users. Am J Obstet Gynecol. 2007;197:620.e1-620.
13. Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic oor dysfunction. Am J Obstet Gynecol. 1996;175:10-17.
14. Coates KW, Harris RL, Cundiff GW, Bump RC. Uroowmetry in
women with urinary incontinence and pelvic organ prolapse. Br J
Urol. 1997;80:217-221.
15. Wu V, Farrell SA, Baskett TF, Flowerdew G. A simplied protocol
for pessary management. Obstet Gynecol. 1997;90:990-994.
16. Handa VL, Jones M. Do pessaries prevent the progression of pelvic
organ prolapse? Int Urogynecol J. 2002;13:349-352.
17. Mutone MF, Terry C, Hale DS, Benson JT. Factors which inuence
the short-term success of pessary management of pelvic organ prolapse. Am J Obstet Gynecol. 2005;193:89-94.

UROLOGY 87 (C), 2016

18. Bhatia NN, Bergman A, Gunning JE. Urodynamic effects of a

vaginal pessary in women with stress urinary incontinence. Am J
Obstet Gynecol. 1983;147:876-884.
19. Bump RC, Fantl A, Hurt G. The mechanism of urinary continence
in women with severe uterovaginal prolapse: results of barrier
studies. Obstet Gynecol. 1988;72:291-295.
20. Romanzi LJ, Chaikin DC, Blaivas JG. The effect of genital prolapse
on voiding. J Urol. 1999;161:581-586.
21. Biering-Sorensen F, Hansen HV, Nielsen PN, et al. Residual urine
after intermittent catheterization in females using two different
catheters. Scand J Urol Nephrol. 2007;41:341-345.
22. Byun SS, Kim HH, Lee E, et al. Accuracy of bladder volume determinations by ultrasonography: are they accurate over entire
bladder volume range? Urology. 2003;62:656-660.

UROLOGY 87 (C), 2016

23. Park YH, Ku JH, Oh SJ. Accuracy of post-void residual urine volume measurement using a portable ultrasound bladder scanner with
real-time pre-scan imaging. Neurourol Urodyn. 2011;30:335-338.
24. Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet.
25. Bergman A, Koonings PP, Ballard CA. Predicting postoperative
urinary incontinence development in women undergoing operation
for genitourinary prolapse. Am J Obstet Gynecol. 1988;158:11711175.
26. Chaikin DC, Groutz A, Blaivas JG. Predicting the need for antiincontinence surgery in continent women undergoing repair of
severeurogenital prolapse. J Urol. 2000;163:531-534.
27. Dietz HP, Haylen BT. Symptoms of voiding dysfunction: what do
they really mean? Int Urogynecol J. 2005;16:52-55.