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MATERIALS AND
METHODS
RESULTS
CONCLUSION
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
support.
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.
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: dingdingdangdang11@126.com;
zhu_julie@vip.sina.com
Submitted: May 22, 2015, accepted (with revisions): July 20, 2015
70
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.
RESULTS
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
71
109 patients
Stage
or
Fitting trial
81 patients
Ring pessary with support
28 patients
Gellhorn
1 week
77 patients continued
4 patients discontinued
1 month
76 patients continued
1 patient discontinued
3 months
73 patients
continued
3 patients
discontinued
Figure 1. Study owchart (the number of patients with advanced pelvic organ prolapse who continued and discontinued
pessary use).
9
Size 1
Size 2
web 3C=FPO
Size 3
30
26
Size 4
Urgency incontinence
Stress incontinence
Baseline
No
Yes
P Value
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
7
49
26
37
27
45
54
19
30
30
36
18
0
17
0
10
0
1
0
0
4
9
6
13
<.001
<.001
<.001
<.001
<.001
.025
Table 2. Urinary ow measurement parameters at baseline and at 3 months in women who were successfully tted with a
ring pessary with support
Variable
Abnormal urinary ow
Parameters, n
Qmax, mL/s
Qmean, mL/s
Vv, mL
PVR, mL
BV, mL
Baseline
42
18.20
7.16
289.38
108
402
5.04
1.49
131.4
140
152
3-mo Follow-up
27.76
12.42
383.90
45
413
18
11.25
5.67
154.50
90
135
P Value
<.001*
<.001y
.005y
<.001y
.016y
.727y
BV, bladder volume; PVR, postvoid residual; Qmax, maximum ow rate; Qmean, mean ow rate; Vv, void volume.
Statistical signicance (P <.05).
* McNemars test.
y
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
SUI.
COMMENT
73
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.
CONCLUSION
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.
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