Material and Methods

This study was approved by the Institutional Review Board at Women and 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 pelvic organ prolapse at the Division of Urogynecology.

Participants were recruited between September 2012 and October 2014 and followed up for up to 12 months. Adult women over the age of 18 years choosing any type of pelvic organ prolapse surgery or anticipating long-term pessary use were included.

All patients underwent preoperative pelvic organ prolapse quantification examinations confirming stage 2 or greater pelvic organ prolapse. Symptomatic pelvic organ prolapse was defined as reporting a bothersome vaginal bulge. Patients could also have other pelvic floor disorder symptoms. We excluded women without symptomatic or documented pelvic organ prolapse, women unable to complete questionnaires because of cognitive or language barriers, and women who planned on using a pessary only short term. All participants signed an informed consent prior to participating in this study.

All women completed baseline questionnaires and posttreatment questionnaires (see Table 1 ). Women undergoing surgery completed posttreatment questionnaires at 6 and 12 months. Women who elected pessary completed posttreatment 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 who discontinued the pessary and/or crossed over to the surgery arm were asked to complete posttreatment questionnaires at the time of pessary discontinuation and prior to the initiation of any additional treatment. Women who crossed over from pessary to surgery also completed questionnaires at 6 and 12 months after surgery.

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

Comprehensive functioning outcomes were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires. This system includes standardized tools to measure comprehensive patient-reported well-being in physical, mental, and social domains that have been validated across multiple medical conditions.

The use of the Patient-Reported Outcomes Measurement Information System 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. Although these measures are comprehensive, their use in pelvic organ prolapse and surgical interventions has been limited.

In this study we used the Patient-Reported Outcomes Measurement Information System short form surveys for the following: (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 domain assesses satisfaction with performing one’s usual social roles and activities, whereas satisfaction with participation in discretionary social activities domain 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.

The Patient-Reported Outcomes Measurement Information System 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 SD. 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 to measure pelvic floor disorder symptoms and the Pelvic Floor Impact Questionnaire-7 to measure pelvic floor disorder impact, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, the Body Image Scale, and the Patient Global Impression of Improvement (after treatment only).

Treatment goals listed by patients were categorized into symptom goals (prolapse symptoms, urinary symptoms, bowel symptoms, pain/discomfort symptoms) and function goals (physical, social, emotional, sexual). These goal categories were chosen based on previous work done in this field. 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 examination 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 pretreatment goals at 12 months. Based on Elkadry et al, Mahajan et al, and Hullfish et al, overall goal attainment after surgery for pelvic floor disorders is approximately 80% short term (3 months). Assuming there is a 20% difference between surgery and pessary treatments for goal attainment, 64 women per group would be needed at an alpha of 0.05 and 80% power. We planned to recruit 80 women per group to account for dropout.

Goals achieved and not achieved and the proportion of patients achieving goals were compared using a χ ² test. Multiple logistic regression was used to identify variables associated with not achieving 1 or more pretreatment goals (<100% goal achievement). Variables with a value of P ≤ .1 on bivariate analysis were assessed for potential confounding and interaction in our models.

For the Patient-Reported Outcomes Measurement Information System functioning scores, we compared mean changes in raw scores for each Patient-Reported Outcomes Measurement Information System domain using paired Student t tests to assess within-group changes and independent Student 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). Values of P ≤ .05 were considered statistically significant.

Results

A total of 160 women were enrolled into the study. In the surgery arm, 72 of 80 (90%) had follow-up, and in the pessary arm, 64 of 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 pessary were older compared with those choosing surgery and had lower baseline Pelvic Floor Distress Inventory-20 and body image scores. The 2 groups were otherwise similar in race, pelvic organ prolapse quantification 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 antiincontinence procedure. During the study period, 31 total pessary patients discontinued pessary use or crossed over to the surgery group. Of these, follow-up data were available for 14 women who discontinued pessary use and 8 who crossed over to the surgery arm. Ninety-seven percent of the women in the surgery arm reported being much better or very much better on the Patient Global Impression of Improvement compared with 70% in the pessary arm at follow-up ( P < .0001).

Regarding baseline goals, women were asked to list and then rank their goals. Table 3 presents the distribution of the top number 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 number 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 with those who continued pessary use.

Table 3

Top goal ranked by patient at baseline, by treatment group ^{a , b}

Goals	Total number	Any symptom goal	Prolapse symptom (bulge) goals	Urinary symptom goals	Bowel symptom goals	Pain/discomfort	Any function goal	Physical function goals	Social function goals	Emotional function goals	Sexual function goals	Other
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 or discontinued	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)
P value		.70	.10	.02	.50	.30	1.0	.70	1.0	.70	1.0	.09

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