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

Condition	Treatment or Intervention
Urinary Incontinence	Behavior: Diet and Exercise

Further Study Details: 

Primary Outcomes: Frequency of incontinent episodes; Predictors of improvement in urinary incontinence
Secondary Outcomes: Reduction in Weight; Maintenance of Weight Loss
Expected Total Enrollment:  330

Three hundred and thirty overweight and obese women with urinary incontinence, 165 from each of two Clinical Centers, will be randomized to either a 6-month intensive behavioral weight control program or to usual care (no weight reduction intervention) and followed for 18 months. Efficacy of weight reduction as a treatment for urinary incontinence will be examined at 6 months following the intensive weight control program, and the sustained impact of the intervention will be examined at 18 months. To increase the maintenance of weight reduction and facilitate evaluation of the enduring impact of weight loss on urinary incontinence, we propose to study a motivation-based weight maintenance program. At the end of the intensive weight control program, women randomized to the weight loss program will be randomized to either a 12-month skill-based maintenance intervention or to a motivation-based maintenance intervention. The maintenance interventions maximize the potential for sustained weight loss and will allow us to determine if long-term weight reduction will produce continued improvement in urinary incontinence.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• aged ≥ 30 years and not institutionalized
• body mass index 25 to 45 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

Exclusion Criteria:

• 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

Judith L Macer, BSc      415 353-9749    jmacer@itsa.ucsf.edu

Alabama
      University of Alabama, Birmingham,  Alabama,  35205,  United States; Recruiting
Arkansas
      University of Arkansas, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      University of California at San Francisco, San Francisco,  California,  94110,  United States; Completed
Rhode Island
      Miriam Hospital/Brown University, Providence,  Rhode Island,  02903,  United States; Recruiting

Study chairs or principal investigators

Deborah Grady, MD, PhD,  Principal Investigator,  UCSF Coordinating Center   
Leslee Subak, MD,  Principal Investigator,  UCSF Coordinating Center   
John Kusek, PhD,  Study Director,  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)   
Lee Nyberg, PhD,  Study Director,  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)   

Study ID Numbers:  1 UO1 DK67860
Record last reviewed:  January 2005
Last Updated:  January 3, 2005
Record first received:  September 21, 2004
ClinicalTrials.gov Identifier:  NCT00091988
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08