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Am J Obstet Gynecol. Author manuscript; available in PMC 2017 November 01.
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Published in final edited form as:

Am J Obstet Gynecol. 2016 November ; 215(5): 659.e1–659.e7. doi:10.1016/j.ajog.2016.06.013.

Patient-reported goal attainment and comprehensive functioning

outcomes after surgery compared to pessary for pelvic organ
prolapse
Vivian W. SUNG, MD, MPH1, Kyle J. WOHLRAB, MD1, Annetta MADSEN, MD1, and Christina
RAKER, ScD2
1TheDivision of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and
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Gynecology, Warren Alpert Medical School at Brown University, Providence, RI

2The Division of Research, Women and Infants Hospital of Rhode Island, Providence, RI

Abstract
Background—Pelvic organ prolapse can negatively impact a woman’s overall functioning.
When choosing between surgery or pessary, many women have information needs about long-term
expectations. While it has been shown that both surgery and pessary can improve prolapse
symptoms, there is less information comparing comprehensive functioning outcomes and goal
attainment between the two treatments.

Objectives—Our primary objective was to compare patient-reported goal attainment and

comprehensive physical, social, and emotional functioning outcomes after surgery versus pessary
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for symptomatic prolapse.

Study Design—We conducted a prospective observational cohort study including women

choosing surgery or pessary for symptomatic stage 2 or greater prolapse. Women undergoing any
modality of prolapse surgery or those anticipating using a pessary long-term to avoid surgery were
eligible. Women completed questionnaires at baseline (pre-treatment) and up to 12 months post-
treatment including: 2) Pre-treatment goals and actual post-treatment goals achieved; 2) five
functioning outcomes encompassing physical, social and emotional function using the Patient-
Reported Outcomes Measurement Information System surveys; 3) validated symptom and quality
of life questionnaires. Treatment goals were categorized into “Symptom Goals” (prolapse, urinary,
bowel, pain) and “Function Goals” (physical, social, emotional, sexual). Goals achieved were
compared using chi-square. Multiple logistic regression was used to identify variables associated
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Correspondence: Vivian W. Sung, MD, MPH, Division of Urogynecology and Reconstructive Pelvic Surgery, Women and Infants’
Hospital / Warren Alpert Medical School at Brown University, 101 Plain Street, 5th Floor, Providence, RI 02903 Phone: 401-274-1122
x 48740 Fax: 401-453-7573, vsung@wihri.org.
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our
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Conflicts of Interest/Disclosure Statement: The authors report no conflicts of interest. Presented at the 42nd Annual Scientific
Meeting of the Society of Gynecologic Surgeons, April 10-13, 2016.
Condensation: Women treated with surgery or pessary for prolapse experience improvements in functioning and goal attainment,
although improvements are greater after surgery.
 SUNG et al. Page 2

with not achieving all pretreatment goals. Mean improvements in functioning scores were
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compared within groups and between groups using paired and independent t-tests. Assuming 80%
of women would achieve complete goal attainment in the surgery group 64 women per group
would be needed to detect a 20% difference at an alpha = 0.05. We recruited 80 women per group
to account for drop out.

Results—A total of 160 women were enrolled and 72 (90%) surgical (mean follow-up 12
months) and 64 (80%) pessary patients (mean follow up 8 months) had post-treatment data. 14
discontinued pessary use and 8 ultimately crossed-over to surgery. At follow-up, a higher
proportion of women in the surgery arm reported successfully achieving symptom goals and
function goals compared to women who chose pessary (P<0.05). Women who continued pessary
use had comparable goal attainment to women in the surgery group for almost all goal categories,
whereas women who discontinued the pessary or crossed-over to surgery had significantly lower
goal attainment compared to both the surgery and pessary continuation groups. On multiple
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logistic regression, only college education or higher was associated with an increased odds of not
achieving all pretreatment goals (OR 2.70, 95% CI 1.1-6.6, P=0.03).

Regarding functioning outcomes, within groups, there were statistically significant improvements
between pre- and post-treatment Patient Reported Outcomes Measurement System functioning
scores in all 5 domains for the surgery group and 4 of 5 domains in the pessary group (P<0.05).
When comparing between groups, women who had surgery reported significantly greater
improvements in the physical function, social roles, and depression domains compared to the
pessary group (P<0.05).

Conclusions—Women undergoing either surgery or pessary for symptomatic prolapse

experience goal attainment and improvements in physical, social and emotional functioning,
although surgery is associated with greater improvements.
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Keywords
pelvic floor disorders; pelvic prolapse; goal; patient-reported outcomes; surgical treatment;
pessary

Introduction
Pelvic organ prolapse (POP) is common, with prevalence rates reported to be as high as 41%
in postmenopausal U.S. women.1 It is projected that the number of U.S. women with POP
will increase 46% between 2010 and 2050 from 3.3 to 4.9 million.2 Both conservative and
surgical options are available for POP. Because treatments for POP are primarily aimed at
improving a woman’s symptoms, functioning and quality of life, information about
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treatment outcomes between options is important for patient decision making.

There is some debate about how to best define POP as a disease3 as well as how to best
define success and failure outcomes after treatment in a standardized fashion.4,5 From a
patient point of view, treatment goals and decisions can be highly individualized since
women can be affected differently.6 Although studies have shown that both surgery and
pessary can improve POP symptoms, in general there is less information regarding
comprehensive functioning outcomes and longer-term goal attainment between the two

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treatment options. The primary objective of this study was to compare goal attainment and
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comprehensive physical, social, and emotional functioning outcomes after surgery versus
pessary for symptomatic POP. We hypothesized that surgery would be associated with
higher goal achievement and improved functioning outcomes compared to pessary.

Material and Methods

This study was approved by the Institutional Review Board at Women & Infants Hospital of
Rhode Island (Providence, RI). We conducted a prospective, observational cohort study
including women choosing either surgery or pessary treatment for symptomatic, Stage 2 or
greater POP at the Division of Urogynecology. Participants were recruited between
September 2012 and October 2014 and followed for up to 12 months. Adult women over the
age of 18 choosing any type of POP surgery or anticipating long-term pessary use were
included. All patients underwent preoperative Pelvic Organ Prolapse Quantification (POPQ)
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examinations7 confirming Stage 2 or greater POP. Symptomatic POP was defined as

reporting a bothersome vaginal bulge. Patients could also have other pelvic floor disorder
(PFD) symptoms. We excluded women without symptomatic or documented POP, women
unable to complete questionnaires due to cognitive or language barriers, and women who
only planned on using a pessary short term. All participants signed an informed consent
prior to participating in this study.

All women completed baseline questionnaires and post-treatment questionnaires (See Table
1). Women undergoing surgery completed post-treatment questionnaires at 6 and 12 months.
Women who elected pessary completed post-treatment questionnaires at 3, 6, and 12
months. We included the 3 month visit for pessary participants to capture potential early
pessary failures and also because the effect of pessary is more immediate. Pessary patients
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who discontinued the pessary and/or crossed-over to the surgery arm were asked to complete
post- treatment questionnaires at the time of pessary discontinuation and prior to initiation of
any additional treatment. Women who crossed-over from pessary to surgery also completed
questionnaires at 6 and 12 months post-surgery.

Questionnaires were self-administered and were completed after initial counseling with the
provider to determine treatment plan, but prior to any treatment initiation (surgery or pessary
placement). For goals, patients were asked to list up to 10 goals of POP treatment and to
rank them in order of importance. This original list was provided to patients at their post-
treatment visits and they were asked to respond whether each pre-treatment goal had been
achieved. Clinical and research staff did not provide assistance in determining goals.

Comprehensive functioning outcomes were measured using the Patient-Reported Outcomes

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Measurement Information System (PROMIS®)8 questionnaires. PROMIS® includes

standardized tools to measure comprehensive patient-reported well-being in physical,
mental, and social domains which have been validated across multiple medical conditions.
The use of PROMIS® outcomes can provide a global assessment of patient well-being that
is efficient, precise, and valid, and allows for comparison across disciplines. Each domain
measure has undergone rigorous psychometric evaluation and refinement and has been
tested across a wide variety of chronic diseases and conditions and in the general population.

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Although these measures are comprehensive, their use in POP and surgical interventions has
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been limited.

In this study we used PROMIS® short form surveys for: 1) Physical function; 2) Satisfaction
with Social Roles; 3) Satisfaction with Participation in Discretionary Social Activities; 4)
Anxiety; and 5) Depression. These were also self-administered. The Physical Function
domain assesses one’s capability to perform a variety of physical activities. The Satisfaction
with Social Roles assess satisfaction with performing one’s usual social roles and activities
whereas Satisfaction with Participation in Discretionary Social Activities assesses
contentment with leisure interests and relationships with friends. The Anxiety domain
assesses fear, anxious misery, hyperarousal, and somatic symptoms. The Depression domain
assesses negative mood, negative views of self, negative social cognition, and decreased
positive affect.
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PROMIS® instruments use a T-score which have a method of interpretation built into the
scoring algorithms. With a T-score, a score of 50 is the average score of the general
population and 10 is equal to one standard deviation. A higher score means more of that
domain. For example, higher scores on physical function indicate better health whereas
higher scores on anxiety indicate poorer health. Patients in this study also completed the
Pelvic Floor Distress Inventory-20 (PFDI-20) to measure PFD symptoms and Pelvic Floor
Impact Questionnaire-7 (PFIQ-7)9 to measure PFD impact, Pelvic Organ Prolapse/Urinary
Incontinence Sexual Function Questionnaire (PISQ-12)10, Body Image Scale (BIS)11, and
Patient Global Impression of Improvement (PGI-I)12 (post-treatment only).

Treatment goals listed by patients were categorized into “Symptom Goals” (prolapse
symptoms, urinary symptoms, bowel symptoms, pain/discomfort symptoms) and “Function
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Goals” (physical, social, emotional, sexual). These goal categories were chosen based on
previous work done in this field.13-15 Goals that did not fit into these categories were
classified as “Other” and were excluded from this analysis. We did not exclude women
based on the types of goals they listed. Two research staff members independently
categorized goals at the end of the study. Any discrepancies were reviewed by a third
research staff member or investigator and adjudicated by consensus. Demographic and
clinical characteristics and physical exam findings were abstracted from chart review.
Patients in both groups were provided $10 for each completed questionnaire and $15 for the
final questionnaire for compensation of their time.

Our primary outcome was achievement of pre-treatment goals at 12 months. Based on

Elkadry13, Mahajan16, and Hullfish14, overall goal attainment after surgery for pelvic floor
disorders is approximately 80% short term (3 months). Assuming there is a 20% difference
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between surgery and pessary treatments for goal attainment, 64 women per group would be
needed at a alpha=0.05 and power 80%. We planned to recruit 80 women per group to
account for drop out.

Goals achieved and not achieved and the proportion of patients achieving goals were
compared using Chi-square. Multiple logistic regression was used to identify variables
associated with not achieving 1or more pretreatment goals (<100% goal achievement).

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Variables with P ≤ 0.1 on bivariate analysis were assessed for potential confounding and
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interaction in our models. For PROMIS functioning scores, we compared mean changes in
raw scores for each PROMIS domain using paired t-tests to assess within group changes and
independent t-tests to compare differences in scores between surgery and pessary groups. All
analyses were performed using STATA/SE 12.0 (Stata Corp., College Station, TX). P-values
≤0.05 were considered statistically significant.

Results
A total of 160 women were enrolled into the study. In the surgery arm 72/80 (90%) had
follow up and in the pessary arm 64/80 (80%) had follow up. Median follow up for the
surgery group was 383 days (range 171-534) and for all pessary users was 223 days (range
11-446). The median follow up for women who continued pessary was 313 days (range
42-446). Clinical and demographic characteristics are presented in Table 2. Women choosing
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pessary were older compared to those choosing surgery and had lower baseline PFDI-20 and
body image scores. The two groups were otherwise similar in race, POPQ stage, prior
prolapse treatment, comorbidities and education level. In the surgery group, 35 (44%)
underwent hysterectomy, 74% underwent some sort of apical suspension, 37% had an
anterior vaginal repair, 52% had a posterior vaginal repair, and 52% underwent a
concomitant anti-incontinence procedure. During the study period, 31 total pessary patients
discontinued pessary use or crossed-over to the surgery group. Of these, follow-up data was
available for 14 women who discontinued pessary use and 8 who crossed-over to the surgery
arm. 97% of women in the surgery arm reported being “much better” or “very much better”
on the PGI-I compared to 70% in the pessary arm at follow up (P<0.0001).

Regarding baseline goals, women were asked to list and then rank their goals. Table 3
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presents the distribution of the top #1 goal ranked by patients. There was no difference
between the surgery and pessary groups in the proportion of women reporting types of
symptom or function goals as their top #1 goal, except a higher proportion of women in the
surgery arm and those who ended up discontinuing the pessary reported having urinary
symptom goals as their top goal compared to those who continued pessary use.

At follow-up, a higher proportion of women in the surgery arm reported successfully

achieving prolapse, urinary, pain/discomfort symptom goals and physical, emotional and
sexual function goals compared to women who chose pessary (See Table 4). We then
compared goal attainment based on pessary continuation and discontinuation. Women who
continued pessary use had comparable goal attainment to women in the surgery group for
almost all goal categories, whereas women who discontinued the pessary or crossed-over to
surgery had significantly lower goal attainment compared to both the surgery and pessary
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continuation groups.

A higher proportion of women in the surgery group achieved 100% of their pretreatment
goals compared to pessary (56% surgery group, 39% pessary continuation group, 5%
pessary discontinuation group, P<0.0001). Of note, achievement of urinary goals was not
different between women who underwent a concomitant anti-incontinence procedure in the
surgery group compared to the pessary group (60% surgery versus 64% pessary group,

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P=0.8). A total of 49 women (36%) reported <100% goal attainment after treatment. On
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multiple logistic regression, only college education or higher was associated with an
increased odds of not achieving 100% of pretreatment goals compared to women who
achieved all of their goals (OR 2.72, 95% CI 1.12- 6.60, P=0.03). Type of treatment, race
and the presence of other pelvic floor disorders were not associated with 100% goal
achievement.

Functioning outcomes between surgery and pessary arms are presented in Table 5. Within
groups, statistically significant improvements in scores were seen between pre- and post-
treatment PROMIS functioning scores in all 5 domains for the surgery group and 4 of 5
domains in the pessary group (the Depression domain did not improve with pessary use).
When comparing between groups, women who had surgery reported significantly greater
improvements in the Physical Function, Social Roles, and Depression domains compared to
the pessary group (P<0.05). When comparing only women who continued pessary use
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versus women in the surgery arm, those who underwent surgery still had significantly
greater improvements in Physical Function (mean change 8.7 vs. 5.2 points, P=0.04) and
Depression scores (mean change 4.0 vs. 0.5, P=0.03). Women who discontinued the pessary
or crossed over to surgery had no significant improvements in any of the PROMIS
functioning questionnaires (P>0.05 for all within group comparisons).

For women who discontinued pessary use, reasons for dissatisfaction included: discomfort
with pessary (47%), still had bulge symptoms (42%), urinary symptoms (32%), bowel
symptoms (21%), inconvenient (16%), and vaginal discharge (5%). These reasons were not
mutually exclusive.

Comment
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In this study, women undergoing either surgery or pessary for symptomatic POP achieve
individual goals and experience improvements in physical, social and emotional functioning
although surgery is associated with greater improvements compared to pessary. Women who
choose to continue with pessary have more comparable improvements in functioning and
goal attainment to the surgery group. Women who discontinued the pessary or crossed over
to surgery had the lowest goal attainment and no improvements in functioning scores.

Goals of POP treatment can be highly individual and variable. In our study, 30% of women
ranked resolution of urinary symptoms as their top goal for POP treatment whereas 18%
ranked resolution of prolapse symptoms (bulge) as the top goal. This is consistent with some
previous studies. In a study by Adams, et al of 226 women presenting for PFD care,
resolution of urinary symptoms was the most commonly stated goal regardless of prolapse
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stage.17 In addition, in our study a higher proportion of women who ended up discontinuing
pessary use or crossing over to surgery reported a top goal of urinary symptom resolution
compared to women who continued with pessary. It is possible that pessary for POP did not
satisfactorily achieve their urinary symptom goals. Komesu et al reported that attainment of
self-stated goals is associated with greatly increased odds of pessary continuation.18
Although there can be many practical reasons why a patient may be dissatisfied with a
pessary, in our study, pessary discontinuation was associated with lack of goal attainment

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and lack of improvement in functioning outcomes as well. In contrast to our findings,

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Shveiky et al found that in a trial of 65 women undergoing treatment of vaginal prolapse

with and without mesh, 57% reported a primary goal of improving prolapse symptoms while
23% reported improving urinary symptoms as a primary goal of prolapse treatment.19 The
reasons for these differences are unclear and it is possible that our patient population may
have had a higher proportion of concomitant lower urinary tract symptoms.

A strength of this study is that we used the PROMIS questionnaires to assess comprehensive
functioning outcomes. There has been significant work done in other fields with these
measures but their use in pelvic floor disorders and surgical interventions has been limited.
In this study, we demonstrated that both surgery and pessary use are associated with
improvements in a wide range of functioning ranging from physical to social to emotional
function. Providing information to patients about functioning outcomes regarding both
treatments can be helpful for patient decision-making. This can also help patients refine their
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individual treatment goals and expectations. Future research should continue to explore and
assess the use of PROMIS® functioning outcomes in pelvic floor disorders as relevant
patient- reported outcome measures.

Limitations of our study include that there may be selection bias between women who
choose surgery versus pessary. For example, there may be different goals and functioning
expectations at baseline, or since surgery confers overall greater risk, it is possible that a
positive outcome would be associated with higher goal attainment. Although our study
showed that women with a college education or higher were more likely to not achieve all
pretreatment goals, the basis for this association is not clear. It is possible that they had
higher and possibly less realistic expectations, but this remains unclear. Women in this study
were recruited from a tertiary care center; therefore, it is possible that desired and achieved
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goals may differ in other populations or in a population with different demographics. Our
goal was to determine long-term goal achievement and functioning and although a large
proportion of women did meet the 12 month follow-up period, the mean follow up time in
the pessary group was shorter due to loss to follow up and overall pessary discontinuation.
Women were asked to list their goals after the initial counseling process with their physician
which may have altered goals and expectations compared to prior to the visit; however, we
do not believe this would bias our study since goals were collected using the same method in
both groups. Finally, we did not exclude women who may have been poor surgical
candidates who were treated with pessary and it is possible that their goals may be different;
however, the median number of comorbidities between the two groups was not different.

In conclusion, our findings highlight that both surgery and pessary treatments lead to
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improvements in patient functioning and goal attainment. Although surgery is associated

with greater improvements, not all women desire surgical treatment and those women who
continue pessary use have comparable functioning and goal attainment outcomes.

Acknowledgments
Funding support: Supported by grant K23HD050108 from the Eunice Kennedy Shriver National Institute of Child
Health and Human Development. The content is solely the responsibility of the authors and does not necessarily
represent the official views of the National Institutes of Health.

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References
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2. Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in
U.S. Women: 2010 to 2050. Obstet Gynecol. 2009; 114:1278–83. [PubMed: 19935030]
3. Swift SE, Barber MD. Pelvic organ prolapse: defining the disease. Female Pelvic Med Reconstr
Surg. 16:201–3.
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surgery: "perspective is everything". Int Urogynecol J.
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7. Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ
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long-term follow-up. Am J Obstet Gynecol. 2004; 191:201–5. [PubMed: 15295366]
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16. Mahajan ST, Elkadry EA, Kenton KS, Shott S, Brubaker L. Patient-centered surgical outcomes: the
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17. Adams SR, Dramitinos P, Shapiro A, Dodge L, Elkadry E. Do patient goals vary with stage of
prolapse? Am J Obstet Gynecol. 2011; 205:502. e1-6. [PubMed: 21907955]
18. Komesu YM, Rogers RG, Rode MA, et al. Patient-selected goal attainment for pessary wearers:
what is the clinical relevance? Am J Obstet Gynecol. 2008; 198:577. e1-5. [PubMed: 18455538]
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19. Shveiky D, Sokol AI, Gutman RE, Kudish BL, Iglesia CB. Patient goal attainment in vaginal
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Table 1

Summary of patient-reported measures completed by participants

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Goals - collected at baseline and Baseline pretreatment goals (Maximum 10, ranked in order
post-treatment of importance by patient)
Post-treatment goals achieved (pretreatment goals re-listed
and patient asked to mark those achieved and not achieved)

Functioning outcomes – collected at Patient-Reported Outcomes Measurement Information

baseline and post- System (PROMIS®) surveys:
treatment
1 Physical Function
2 Satisfaction with Social Roles
3 Satisfaction with Participation in Discretionary Social Activities
4 Anxiety
5 Depression

Other pelvic floor disorder 1 Pelvic Floor Distress Inventory-Short Form

questionnaires - collected at
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baseline and post-treatment 2 Pelvic Floor Impact Questionnaire – Short Form

3 Patient Global Impression of Improvement
4 Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire
-12
5 Body Image Scale
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Table 2

Demographic and clinical characteristics of study population

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Total Surgery Pessary P-value

(n=160) (n=80) (n=80)

Age 61.6 (11.8) 59.0 (10.0) 64.2 (13.0) 0.005

Mean (SD)

Comorbidities 1 (0 - 4) 1 (0 - 3) 1 (0 - 4) 0.4
Median (Range)

POPQ Stage 3 (1-4) 2 (1-4) 3 (1-4) 0.04

(median, range)

Presence of Other 99 (61.9) 52 (65.0) 47 (58.8) 0.5

PFDs (any)

Hispanic* 4 (2.5) 3 (3.8) 1 (1.3) 0.6

Race 149 (93.1) 77 (96.3) 72 (90.0) 0.1

White 1 (0.6) 1 (1.3) 0 (0.0)
Black 10 (6.3) 2 (2.5) 8 (10.0)
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All Other

Education* 46 (29.1) 24 (30.0) 22 (28.2) 0.9

High school or less 112 (70.9) 56 (70.0) 56 (71.8)
College or PG degree

PFDI score 115.4 (58.8) 126.4 (58.3) 104.0 (57.5) 0.02

Mean (SD)

PISQ score 35.8 (6.7) 34.9 (7.6) 37.0 (5.1) 0.2

Mean (SD)

Body image score 27.0 (25.6) 31.7 (27.8) 22.2 (22.3) 0.02
Mean (SD)

*
Numbers may not add to 100% due to missing responses
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Table 3

Top goal ranked by patient at baseline, by treatment group* †

Total Any Prolapse Urinary Bowel Pain / Any Physical Social Emotional Sexual Other
N symptom symptom symptom symptom discomfort function function function function function
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goal (bulge) goals goals goals goal goals goals goals goals

Surgery 80 58 (72.5) 11 (13.8) 31 (38.8) 6 (7.5) 10 (12.5) 21 (26.3) 15 (18.8) 1 (1.3) 2 (2.5) 3 (3.8) 1 (1.3)

Pessary-continued 47 32 (68.1) 13 (27.7) 7 (14.9) 1 (2.1) 11 (23.4) 13 (27.7) 12 (25.5) 0 0 1 (2.1) 2 (4.3)

Pessary –crossover 31 20 (64.5) 4 (12.9) 10 (32.3) 2 (6.5) 4 (12.9) 8 (25.8) 7 (22.6) 0 0 1 (3.2) 3 (9.7)
or discontinued

P-value 0.7 0.1 0.02 0.5 0.3 1.0 0.7 1.0 0.7 1.0 0.09

*
Symptom goals include prolapse, urinary, bowel, or pain/discomfort symptoms. Function goals include physical, social, emotional, and sexual function goals
†
2 women in pessary group did not report any baseline goals

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Table 4

Post-treatment goal attainment by treatment group and goal category*

Goals achieved
SUNG et al.

Total All symptom Prolapse Urinary Bowel Pain/discomfort All function Physical Social Emotional Sexual Other
N goals goals goals goals goals function function function goals function goals
goals goals goals

Surgery 72 43/59 (72.9) 24/25 27/39 5/8 23/25 31/43 26/31 4/6 4/5 10/16 (62.5) 5/5
(96.0) (69.2) (62.5) (92.0) (72.1) (83.9) (66.7) (80.0) (100)

All pessary users 63 42/60 (70.0) 23/29 23/36 5/7 20/25 (80) 27/44 22/35 (62.9) 4/5 (80.0) 6/7 (85.7) 3/9 (33.0) 3/8
(79.3) (63.9) (71.4) (61.4) (37.5)

Pessary-continued 42 35/41 (85.4) 19/21 17/21 4/5 17/17 26/28 21/22 4/4 6/6 3/4 (75.0) 3/5
(90.5) (81.0) (80.0) (100) (92.9) (95.5) (100) (100) (60.0)

Pessary –crossover 21 7/19 (36.8) 4/8 (50.0) 6/15 1/2 3/8 1/16 (6.3) 1/13 0/1 0/1 0/5 0/3 (0)
or discontinued (40.0) (50.0) (37.5) (7.7) (0) (0) (0)

† 0.0007 0.006 0.04 1.0 0.0003 <0.0001 <0.0001 0.2 0.08 0.03 0.02
P-value

*
Data represent women who reported having baseline goals in each category that were subsequently achieved after treatment
†
P-value compares surgery, pessary-continued, and pessary-crossover/discontinued groups.

Am J Obstet Gynecol. Author manuscript; available in PMC 2017 November 01.

Page 12
 SUNG et al. Page 13

Table 5

Functioning outcomes by treatment group

Author Manuscript

Baseline Post-treatment Change Within group P- Between group P-

mean score (SD) mean score (SD) mean score (SD) value value

PROMIS Physical Function*

Surgery 45.0 (7.5) 53.7 (9.3) 8.7 (8.8) <0.0001

0.0004
Pessary 48.1 (7.6) 51.6 (9.2) 3.5 (6.9) 0.0003

PROMIS Social Roles

Surgery 50.8 (10.6) 57.1 (9.6) 6.3 (10.5) <0.0001
0.049
Pessary 54.2 (10.1) 57.0 (9.9) 2.8 (9.3) 0.02

PROMIS Social Discretionary

Surgery 52.0 (9.8) 57.1 (9.8) 5.1 (8.9) <0.0001
0.07
Pessary 54.0 (10.0) 56.4 (10.1) 2.4 (7.7) 0.02
Author Manuscript

PROMIS Anxiety*

Surgery 54.0 (10.5) 49.1 (10.1) −5.0 (10.3) 0.0001

0.3
Pessary 49.9 (9.4) 46.7 (9.9) −3.2 (9.1) 0.008

PROMIS Depression*
Surgery 51.1 (9.4) 47.0 (9.9) −4.0 (9.4) 0.0006
0.02
Pessary 45.7 (8.2) 45.0 (9.2) −0.6 (7.1) 0.5

*
P<0.05 for baseline PROMIS scores between Surgery vs. Pessary group for Physical Function, Anxiety, and Depression domains.
Author Manuscript
Author Manuscript

Am J Obstet Gynecol. Author manuscript; available in PMC 2017 November 01.