Program to Reduce Incontinence by Diet and Exercise

Completed · Not applicable

Conditions studied: Urinary Incontinence

In brief

PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.

Key facts

Study ID

NCT00091988

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

338

Starts

2004-07-01

Expected to finish

2007-11-01

Last updated by the study team

2020-04-16

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• aged ≥ 30 years and not institutionalized
• body mass index 25 to 50 kg/m2
• urinary incontinence symptoms for > 3 months by self-report and record > 10 incontinent episodes per week on a 7-day urinary diary
• able to complete a behavioral run-in consisting of self-monitoring of food and activity
• report having a primary health care provider
• able to understand and sign informed consent and complete baseline questionnaires
• agree to not initiate new treatment for incontinence or weight reduction, including behavioral, pharmacological or surgical therapies, for the duration of the study

You may not qualify if…

• current use, or use within the previous month of medical therapy for incontinence
• currently pregnant or gave birth in the previous 6 months
• current urinary tract infection (dipstick urinalysis positive for leukocyte esterase, nitrites or blood) or report having > 4 urinary tract infections in the preceding year
• incontinence of neurologic or functional origin (by history)
• self-report of prior anti-incontinence or urethral surgery, pelvic cancer or pelvic irradiation
• self-report of significant medical conditions of the genitourinary tract (genitourinary fistula, interstitial cystitis, symptomatic pelvic organ prolapse)
• report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity, including type 2 diabetes requiring medical therapy that may cause hypoglycemia, chronic steroid use or uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure > 100 mm Hg); women with a history of coronary heart disease may participate with written approval from their primary care physician
• currently engaged in an active weight loss program and/or experienced a 10% or greater weight reduction in the past 3 months
• report being unable to walk 2 blocks (1/4 mile) without stopping
• report conditions that, in the judgment of the Clinical Center Principal Investigator, render potential participants unlikely to follow the protocol for 18 months, including illness likely to be terminal within 2 years, plans to move, substance abuse or other significant psychiatric problems, or dementia
• participating in another research study that involves investigational drugs or can potentially confound the results of PRIDE

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Arkansas — Little Rock, Arkansas, United States
• University of California at San Francisco — San Francisco, California, United States
• Miriam Hospital/Brown University — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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