American Journal of Obstetrics and Gynecology (2004) 190, 1025e9

www.elsevier.com/locate/ajog

Patient satisfaction and changes in prolapse and urinary

symptoms in women who were fitted successfully with
a pessary for pelvic organ prolapse
Jeffrey L. Clemons, MD,a Vivian C. Aguilar, MD,b Tara A. Tillinghast, NP, MSN,b
Neil D. Jackson, MD,b Deborah L. Myers, MDb

Departments of Obstetrics and Gynecology, Divisions of Urogynecology and Pelvic Reconstructive Surgery, Madigan
Army Medical Center, Tacoma, Wash,a and Brown University Medical School, Providence, RIb

Received for publication June 30, 2003; revised October 7, 2003; accepted October 23, 2003

KEY WORDS Objective: Our purpose was to estimate, in women after 2 months of pessary use, patient satisfac-
Pessary tion and the percentage of prolapse and urinary symptoms that improve or worsen.
Pelvic organ prolapse Study design: In a prospective study, 100 consecutive women with symptomatic pelvic organ pro-
Satisfaction lapse were tted with a pessary, and 73 women had a successful 2-week pessary tting trial. Pro-
Prolapse symptom lapse and urinary symptoms were assessed at baseline and at 2 months. Patient satisfaction was
Urinary symptom assessed at 2 months. Risk factors for patient dissatisfaction were assessed.
Results: Nearly all prolapse symptoms resolved from baseline to 2 months, respectively: bulge
(90% to 3%; P!.001), pressure (49% to 3%; P!.001), discharge (12% to 0%; P = .003), and
splinting (14% to 0%; P = .001). Among women with concurrent urinary symptoms at baseline,
stress incontinence improved in 45%, urge incontinence improved in 46%, and voiding difculty
improved in 53%, after 2 months. However, among women without urinary symptoms at base-
line, occult (de novo) stress incontinence occurred in 21%, de novo urge incontinence occurred in
6%, and de novo voiding difculty occurred in 4%. At 2 months, 92% of the women were sat-
ised with their pessary. Six women (8%) were dissatised and discontinued use of the pessary.
Dissatisfaction was associated with occult stress incontinence (odds ratio, 17.1; 95% CI, 1.9, 206;
P = .004).
Conclusion: After 2 months, 92% of women with a successful pessary tting trial were satised.
Nearly all prolapse symptoms resolved after 2 months; 50% of urinary symptoms improved, but
occult stress incontinence was a common side eect.
2004 Elsevier Inc. All rights reserved.

The opinions or assertions contained herein are the private views of Reprint requests: Jerey L. Clemons, MD, Department of
the authors and are not to be construed as ocial or as reecting the Obstetrics & Gynecology, Madigan Army Medical Center, Tacoma,
views of the Department of the Army or the Department of Defense. WA 98431.
Presented at the Annual Meeting of the American Urogynecologic E-mail: Jeffrey.Clemons@nw.amedd.army.mil
Society, San Francisco, California, October 17, 2002.

0002-9378/$ - see front matter 2004 Elsevier Inc. All rights reserved.
doi:10.1016/j.ajog.2003.10.711
1026
Pelvic organ prolapse is a common condition that af-
fects 30% of women aged 20 to 59 years in Sweden.1 The
2 methods of treatment for symptomatic pelvic organ
prolapse are insertion of a vaginal pessary or pelvic re-
constructive surgery. The lifetime risk of undergoing
surgery for prolapse or urinary incontinence by age 80
years is reported to be 11%.2 Given that the risk of re-
current pelvic organ prolapse after surgery is at least
10% to 20%,3,4 initial conservative treatment with a pes-
sary is worthwhile, especially if success rates are similar.
Symptoms that are associated with pelvic organ pro-
lapse include a vaginal bulge, pelvic pressure, vaginal
splinting, urinary incontinence, voiding dysfunction,
urinary retention, constipation, vaginal erosions, and
sexual dysfunction. Previous studies have shown pessa-
ries to be useful in the treatment of women with pelvic
organ prolapse,5-7 but there is minimal data regarding
outcomes (such as patient satisfaction, change in pro-
lapse symptoms, or change in urinary symptoms). Our
standard practice is to offer a pessary in all women with
symptomatic prolapse to diagnose occult stress inconti-
nence and to offer a trial of nonsurgical treatment. Our
purpose was to determine, among women with a success-
ful pessary tting trial, patient satisfaction after 2
months of use and the percentage of prolapse and uri-
nary symptoms that improve or worsen.
Methods
Between March 2001 and August 2002, we conducted
a prospective, observational study that was approved
by our Institutional Review Board. One hundred con-
secutive women with symptomatic pelvic organ pro-
lapse, stage II or greater, were offered a pessary.
Seventy-three women had a successful pessary tting
trial and represent the cohort for this study. Baseline
demographic data, comorbidities, prolapse and urinary
symptoms, and sexual activity were recorded. Women
were considered poor surgical candidates if they had se-
vere comorbidities (for example, severe cardiovascular
disease, severe osteoporosis with multiple compression
fractures, steroid-dependent chronic obstructive pulmo-
nary disease, or dementia). The prolapse symptoms that
were assessed were vaginal bulge, pelvic pressure, vagi-
nal discharge, and a need for splinting to void or defe-
cate. The urinary symptoms that were assessed were
stress incontinence, urge incontinence, and voiding dif-
culty. Women were asked whether they intended to un-
dergo pelvic reconstructive surgery.
All women were examined, and pelvic prolapse was
staged by the pelvic organ prolapse quantication sys-
tem.8 Methods, denitions, and descriptions conform
to the standards that were recommended by the Interna-
tional Continence Society. Women were examined on
a standard pelvic examination table in the dorsal lithot-
Clemons et al
omy position. All examinations were performed with an
empty bladder, after a catheterization for a postvoid
urine residual. A split speculum examination was used
to stage the prolapse.
One hundred women were tted with either a ring
(with diaphragm) or Gellhorn pessary (Milex, Chicago,
Ill) and returned 1 week later to assess t. The largest
pessary that was comfortable for the woman was used.
If necessary, she was retted with a different pessary 1
week later. The details of the pessary tting trial were re-
ported previously.9 Essentially, ring (support) pessaries
were attempted rst, followed by Gellhorn (space-occu-
pying) pessaries, because we have found in our practice
that nearly all women with prolapse can be tted with 1
of these pessaries. A woman had a successful pessary t-
ting trial if she was (1) tted with a pessary at the rst
visit and continued to use it 1 week later or (2) retted
with a new pessary at the second visit and continued
to use it 1 week later. An unsuccessful pessary tting tri-
al occurred if the woman discontinued the pessary be-
cause of discomfort or expulsion. Seventy-three of the
100 women had a successful pessary tting trial and rep-
resent the cohort for this study. Women were allowed to
continue pessary use if they were tted successfully. Mo-
tivated patients were taught how to insert and remove
their pessary. All women returned for follow-up at
2 months.
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?
(3) Do you have vaginal discharge? (4) Do you need to
insert your ngers into your vagina (splint) to void urine
or have a bowel movement? For each question, there
were 5 possible replies. For data analysis, replies of
never or rarely were recorded as no, whereas re-
plies of sometimes or usually or always were re-
corded as yes. At 2 months, women were asked the
same questions again, and their replies were coded the
same way.
Similarly, regarding urinary symptoms, 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? For
data analysis, replies of never or rarely were re-
corded as no, whereas replies of sometimes or usu-
ally or always were recorded as yes. At 2 months,
women were asked the same questions again, and their
replies were coded the same way. A symptom was re-
solved if the baseline reply was yes and the 2-month
reply was no. A symptom was persistent if the base-
line reply was yes and the 2-month reply was yes,
with the exception that a symptom was improved if
the baseline reply was usually or always and the
2-month reply was sometimes. A symptom was
Clemons et al 1027

Table I Prolapse symptoms at baseline and at 2 months in Table II Changes in urinary symptoms from baseline to 2
women who were fitted successfully with a pessary (n = 73) months in women who were fitted successfully with a pessary
Women with Women with (n = 73)
Prolapse symptoms at symptoms 2-Month
symptom baseline (n) at 2 mo (n) P value* Symptom Baseline % (n) follow-up % (n)
Bulge 66 (90%) 2 (3%) !.001 Stress Yes 27 (20) Yes (persist) 55 (11)
Pressure 35 (49%) 2 (3%) !.001 incontinence No (improve 45 (9)
Discharge 9 (12%) 0 .003 or resolve)
Splinting 10 (14%) 0 .001 No 73 (53) Yes (de novo) 21 (11)
* Fishers exact test No 79 (42)
Urge Yes 36 (26) Yes (persist) 54 (14)
de novo if the baseline reply was no and the 2-month incontinence No (improve 46 (12)
or resolve)
reply was yes.
No 64 (47) Yes (de novo) 6 (3)
Regarding patient satisfaction, the women were
No 94 (44)
asked at 2 months: Are you satised with your pessary?
The 4 possible replies were very satised, somewhat Voiding Yes 23 (17) Yes (persist) 47 (8)
satised, somewhat dissatised, or very dissatis- difficulty No (improve 53 (9)
ed. They were also asked whether they had any pain, or resolve)
No 77 (56) Yes (de novo) 4 (2)
expulsion, bleeding, or difculty with defecation that
No 96 (54)
was associated with the pessary. The pessary was re-
moved and cleaned, and the vagina was examined for
erosions. If erosions were noted, then the woman was in-
structed to start using estrogen vaginal cream daily and pression fractures; 5% had steroid-dependent chronic
to return weekly, until the erosion resolved. The pessary obstructive pulmonary disease, and 7% had dementia.
was reinserted in women who were satised with their On pelvic organ prolapse quantication staging, 27%
pessary. Women who changed the pessary themselves re- (20 women) had stage II prolapse, 58% (42 women) had
turned for follow-up every 6 to 12 months; otherwise, stage III prolapse, and 15% (11 women) had stage IV
they returned for follow-up every 2 to 3 months. prolapse. The median prolapse stages for each compart-
Demographic data, comorbidities, prolapse and uri- ment were stage III anterior vaginal wall prolapse (range
nary symptoms, and physical examination ndings were I-IV), stage II posterior vaginal wall prolapse (range I-
summarized with the use of means, medians, and per- IV), and stage II vault/uterine prolapse (range I-IV).
centages. Fishers exact test was used to compare the Fifty-four women (74%) used ring pessaries, and
percentage of women with prolapse symptoms at base- 19 women (26%) used Gellhorn pessaries. Twenty-
line and at 2 months. Ninety-ve percent condence in- one women (29%) were taught to insert and remove
tervals (CI) were calculated for changes in urinary their pessary, all of whom were ring pessary users, be-
symptoms. Odds ratios were calculated to identify risk cause the Gellhorn pessary was too difcult for women
factors for patient dissatisfaction. Probability values of to remove and reinsert. There was no difference between
!.05 were considered statistically signicant. All statis- the ring and Gellhorn pessary when compared with the
tical methods were performed with the SAS software clinical outcomes listed later.
package (SAS Institute Inc, Cary, NC). Prolapse and urinary symptoms were assessed at
baseline and at 2 months in the 73 women. At baseline,
the 2 most common prolapse symptoms were a bulge
Results (90%) and pelvic pressure (49%). Every woman had at
least 1 of these 2 symptoms. Symptoms of vaginal dis-
The mean age of the 73 women was 71 years (range, 40- charge (12%) and splinting to void or defecate (14%)
92); mean parity was 3.2 (range, 0-12); 92% were white; were less common. All 4 prolapse symptoms were im-
89% were postmenopausal; 33% were taking estrogen proved signicantly with the use of a pessary. Nearly
replacement therapy; 48% had a previous hysterectomy; all of the prolapse symptoms that were reported by the
41% had previous pelvic reconstructive surgery, and women at baseline resolved at 2 months (Table I).
42% were sexually active. Twenty-six percent did not Regarding urinary symptoms at baseline, 27% of the
want to have surgery; 23% desired surgery, and 51% women reported stress incontinence; 36% reported urge
were equivocal. Nineteen percent were considered poor incontinence, and 23% reported voiding difculty (Ta-
surgical candidates due to one or more of the following ble II). Approximately one half of the urinary symptoms
severe comorbidities: 7% had severe cardiovascular dis- that were reported by the women at baseline improved
ease; 5% had severe osteoporosis with multiple com- or resolved at 2 months: stress incontinence improved
1028
in 45% (95% CI, 26%, 66%); urge incontinence im-
proved in 46% (95% CI, 29%, 65%), and voiding dif-
culty improved in 53% (95% CI, 31%, 74%). However,
among women without urinary symptoms at baseline,
occult (de novo) stress incontinence developed in 21%
(95% CI, 12%, 34%). De novo urge incontinence and
de novo voiding difculty were uncommon, occurring
in only 6% (95% CI, 2%, 18%) and 4% (95% CI,
0%, 13%) of the women, respectively.
At 2 months, 67 of the 73 women were either very
satised or somewhat satised with their pessary, trial are reported to be satised. Overall (intention-to-
for a satisfaction rate of 92%. Six of the 73 women were
either somewhat dissatised or very dissatised tially with a pessary for prolapse are reported to be sat-
with their pessary, for a dissatisfaction rate of 8%.
These 6 women discontinued their pessary during the
rst 2 months because of side effects: 4 women had se-
vere occult stress urinary incontinence; 1 woman had
de novo voiding difculty, and 1 woman had de novo
defecation difculty. Patient dissatisfaction was associ-
ated with the development of occult stress incontinence
(odds ratio, 17.1; 95% CI, 1.9, 206; P = .004), but not
de novo voiding difculty (P = .16) or de novo defeca-
tory difculty (P = .08).
As noted earlier, 42% of the women (31 of 73) who
were tted with a pessary successfully were sexually ac-
tive at baseline. Twenty-eight women (90%) were able to
continue sexual activity, because they were tted with
ring pessaries (the other 3 women were tted with Gell-
horn pessaries, which precluded intercourse). Vaginal
erosions developed in 2 women; neither woman initially
used vaginal estrogen cream, but the erosions resolved
with daily vaginal estrogen cream and continued use
of the pessary. No other complications were noted.
Comment
In this prospective study of 73 women with a successful
pessary tting trial for symptomatic pelvic organ pro-
lapse, almost all prolapse symptoms resolved, and
92% of the women were satised at 2 months of fol-
low-up. From an intention-to-treat perspective, of the
100 women who were treated originally with a pessary
for symptomatic pelvic organ prolapse (including the
27 women with an unsuccessful pessary tting trial),
67% of the women were satised. It was not surprising
that prolapse symptoms resolved with the use of a pes-
sary, but this has not been well documented in the liter-
ature. Satisfaction with pessary use has been reported in
3 studies, with the implication that prolapse symptoms
were improved. In a retrospective study by Sulak et al,6
101 women were treated with a pessary for symptomatic
pelvic organ prolapse (82 women), urinary incontinence
(9 women), or both (10 women), and 50% of the women
were satised and used the pessary for a mean of 16
months. In a prospective study by Wu et al,5 62 of 110
Clemons et al
women (56%) with symptomatic pelvic organ prolapse
had a successful pessary tting trial. Among these 62
women, 77% were satised after 6 months, and 64%
were satised after 2 years. Including all 110 women (in-
tention-to-treat), the satisfaction rate was 44% after 6
months and 31% after 2 years. In a prospective study
by Handa and Jones,7 64% of 56 women treated with
a pessary for symptomatic pelvic organ prolapse were
satised at 3 months. Therefore, after 2 to 6 months,
77% to 92% of women with a successful pessary tting
treat), 44% to 67% of all women who were treated ini-
ised after 2 to 6 months.
In our study, concurrent stress incontinence symp-
toms were reported at baseline by 27% of the women
with symptomatic pelvic organ prolapse, and 45% of
these women reported improvement or resolution at 2
months. Sulak et al6 reported 19 women with stress in-
continence (10 women with prolapse and incontinence
and 9 women with incontinence only). Six women
(32%) continued to use their pessary and reported im-
provement or cure of their incontinence symptoms.
However, the retrospective design of the study limited
their ability to determine the effect of the pessary on in-
continence symptoms. Vierhout and Lose10 reviewed
studies of women who were treated with a pessary for
stress urinary incontinence only (without pelvic organ
prolapse) and reported an overall subjective improve-
ment or cure rate of 63% after 1 month. We will continue
to follow our cohort of women with symptomatic pelvic
organ prolapse to determine whether improved stress in-
continence symptoms correlates with continued pessary
use at 1 year.
Concurrent voiding difculty and prolapse were eval-
uated by Romanzi et al,11 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 women (94%) had resolution of
their obstruction. Although we did not assess urethral
obstruction, our 53% overall improvement in concur-
rent voiding difculty with pessary use is similar to their
68% (17/25 women) resolution of urethral obstruction
with pessary use in women with grade 3 or 4 cystocele.
Occult (de novo) stress incontinence was a common
side effect in our study, and was associated with patient
dissatisfaction. Of the 53 continent women with symp-
tomatic pelvic organ prolapse, 21% experienced occult
stress incontinence with use of a pessary. Among women
with more severe (stage III or IV) anterior vaginal wall
prolapse, the rate was 22%. Several studies have evalu-
ated continent women with severe pelvic organ prolapse
with a pessary to determine the frequency of occult or
potential stress urinary incontinence. Occult stress uri-
nary incontinence was reported by several authors with
Clemons et al
a range of 36% to 72%.12-15 The rate may have been
lower in our study because of a possible therapeutic ben-
et from the pessary. Bhatia et al16 demonstrated an in-
crease in functional urethral length and urethral closure
pressure in 12 women who were treated with a pessary
for stress incontinence. Although occult stress inconti-
nence was associated with patient dissatisfaction in our
study, only 36% of the women with occult stress incon-
tinence had symptoms that were severe enough that they
wished to discontinue their pessary. Most women pre-
ferred the use of the pessary and the side effect of mild
stress incontinence to the discomfort from the pelvic or-
gan prolapse. In women with concurrent symptomatic
pelvic organ prolapse and stress urinary incontinence
who desire conservative treatment, the use of a pessary
plus collagen injection of the urethra remains a viable
option.17
A strength of this study is that a pessary was offered to
all women with symptomatic pelvic organ prolapse, not
just to women who were poor surgical candidates or
who declined surgery, thereby giving a more accurate
estimate of the effect of the pessary on prolapse and
urinary symptoms. A limitation of our study is that
a nonvalidated questionnaire was used to obtain subjec-
tive data (satisfaction and changes in symptoms) from
the women. We routinely ask these questions of our pa-
tients at baseline and follow-up. We may have also intro-
duced ascertainment bias, because we verbally asked the
questions, but we tried to obtain an honest assessment of
their symptoms. Validated instruments such as the short
forms of the urogenital distress inventory and inconti-
nence impact questionnaire18 would have improved our
study. Another limitation of this study is that there was
no control group, so we are unable to state conclusively
that the improvements in urinary symptoms were due to
the pessary or to other behavioral changes (pelvic muscle
exercises, dietary restrictions, bladder retraining). Addi-
tionally, outcomes were assessed only at 2 months, so
long-term results cannot be established. We will continue
the follow-up visits for 1 year for the 67 women who were
still using the pessary at 2 months to better determine
long-term use, satisfaction and safety.
The vaginal pessary is a simple, inexpensive, and ef-
fective method of treatment for pelvic organ prolapse.
In women who are tted successfully with a pessary, pa-
tient satisfaction is relatively high. Comparison of
patient satisfaction between pessaries and pelvic
reconstructive surgery in women with pelvic organ pro-
lapse has not been reported. Future studies will need to
compare pessary use and pelvic reconstructive surgery in
women with symptomatic pelvic organ prolapse. Be-
cause the risk of recurrent pelvic organ prolapse after
1029
surgery is at least 10% to 20%,3,4 initial conservative
treatment with a pessary is worthwhile.
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