The PRIDE study was a randomized controlled trial evaluating the effect of a 6-month intensive lifestyle and behavioral change intervention vs a structured education program to promote weight loss in 338 overweight and obese women with incontinence.13
To be eligible women had to be at least 30 years old, have a BMI of 25 to 50 kg/m2
and self-report at least 10 episodes of incontinence weekly on a screening voiding diary. Women were excluded from study if they reported any condition that would prevent them from safely participating in an intensive diet and exercise program without medical supervision, or if they had undergone medical therapy for incontinence or weight loss in the previous month.13
Participants were recruited from the local community at the Miriam Hospital in Providence, Rhode Island and the University of Alabama in Birmingham, and randomly allocated in a 2:1 ratio to the lifestyle and behavior change program (intervention 226) or to the structured education program (control 112) (see ). With the exception of 3 staff members at the coordinating center who prepared analyses for the Data and Safety Monitoring Board, investigators and outcomes assessors were blinded to treatment assignment. Informed consent was obtained from all participants, and the institutional review boards at both clinical sites and the coordinating center approved all study procedures.
All study participants were given a self-help booklet which presented basic information about urge and stress incontinence, instructions for completing bladder diaries, information about performing pelvic floor muscle exercises and cognitive/behavioral strategies for managing urinary urgency. Women randomized to the control group were also assigned to participate in 1-hour group educational sessions at months 1, 2, 3 and 4, providing general information about weight loss, physical activity, healthy eating habits and health promotion (the structured education program).
Women in the intervention group were assigned to an intensive lifestyle and behavior change program modeled after the Diabetes Prevention Program and Look AHEAD (Action for Health in Diabetes) trials designed to produce an average loss of 7% to 9% of initial body weight by 6 months.14
This program included weekly 1-hour group sessions led by experts in nutrition, exercise and behavior change in which women were encouraged to increase physical activity to at least 200 minutes weekly using brisk walking or activities of similar intensity, and to record exercise time daily. Additionally, women were given a reduced calorie diet (1,200 to 1,500 kcal daily), offered sample meal plans modeling appropriate food selections and provided with vouchers for meal replacement products.
Frequency and clinical type of urinary incontinence were assessed at baseline and 6-month followup using 7-day self-report bladder diaries.13
Women were considered to have stress predominant incontinence if at least two-thirds of the incontinence episodes were identified as stress type (involuntary urine loss associated with coughing, sneezing, straining or exercise) and to have urge predominant incontinence if at least two-thirds of episodes were urge type (involuntary urine loss associated with a strong need or urge to void). The remaining women were considered to have mixed or other incontinence. Clinical incontinence severity was determined using a modified Sandvik Severity Index based on frequency of urine loss as well as the average amount of urine loss per episode (assessed using the question, “How much urine do you typically lose with each episode?” “Drops/small splashes/more”).15
Sexual function was assessed at baseline and at 6 months using self-administered questionnaires that participants completed in private and submitted to study personnel in sealed envelopes. Questionnaire items were drawn from the Female Sexual Function Index16
and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire17
but were adapted to assess sexual function in the 3 months before each visit. The questionnaire included several measures of overall sexual function that were administered to all participants regardless of sexual activity, as well as several measures to assess general and incontinence specific sexual problems among those who had been sexually active in the previous 3 months (Appendix 1
). For the purposes of this study women were considered sexually active if they reported “any activity that is arousing to [them], including masturbation.”
Other variables assessed by self-report included demographic characteristics, reproductive history, menopausal history, history of hysterectomy and oophorectomy, and use of medications. Symptoms of depression were assessed by the Beck Depression Inventory, a self-administered screening instrument in which higher scores indicate more severe symptoms.18
Overall health status was assessed by asking participants to rate their general health as excellent, very good, good, fair or poor. Body weight and height were measured for BMI calculation at baseline and at 6 months.
We examined associations between participant characteristics and self-reported sexual function outcomes at baseline using multivariable models. To assess overall sexual functioning outcomes measured on an ordinal scale (ie frequency of sexual activity, sexual desire and sexual satisfaction) we used GEE multinomial models, adjusting for clinical site and accounting for clustering within intervention groups.19
For sexual problems outcomes measured using multi-item summated scales (ie the “Urine leakage during sexual activity” and “Difficulties with sexual activity” scales), we treated the average value across scale items for each participant as a continuous outcome, and used GEE linear models to adjust for site and clustering within intervention groups.19
Only sexually active participants were included in models assessing sexual problems outcomes that were contingent upon activity. Age, race, partner status, parity, hysterectomy, oophorectomy, menopausal status, general health, depression symptoms, systemic estrogen use, SSRI use, clinical severity of incontinence, clinical type of incontinence, BMI and clinical site were included in all models.
We then examined the effect of the PRIDE intensive behavioral change vs structured education intervention on sexual functioning from the baseline to the 6-month visit. To adjust for clinical site and account for clustering within intervention groups we again used GEE multinomial models to assess outcomes measured using ordinal scales and linear models to assess outcomes measured using multi-item summated scales.19
In addition, we examined the relationship of change in frequency of incontinence and BMI to change in sexual function during 6 months using GEE multinomial or linear models as appropriate. All analyses were performed using SAS® statistical software version 9.1.