Clinical trial NCT00091988: Program to Reduce Incontinence by Diet and Exercise
Official title: Program to Reduce Incontinence by Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Weight Loss
Obesity
Motivation
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of California, San Francisco
First posted: 2004-09-22
Enrollment: 338
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Change in the number of incontinent episodes
timeFrame: 6 months
Secondary outcomes:
measure: Change in body weight at 6 months
timeFrame: 6 months
measure: Change in body weight at 12 months
timeFrame: 12 months
measure: Change in body weight at 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Providence
country: United States
facility: Miriam Hospital/Brown University
state: Rhode Island
Study officials:
affiliation: UCSF Coordinating Center
name: Deborah Grady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Coordinating Center
name: Leslee Subak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: John Kusek, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Lee Nyberg, PhD
role: STUDY_DIRECTOR
References:
citation: Myers DL, Sung VW, Richter HE, Creasman J, Subak LL. Prolapse symptoms in overweight and obese women before and after weight loss. Female Pelvic Med Reconstr Surg. 2012 Jan-Feb;18(1):55-9. doi: 10.1097/SPV.0b013e31824171f9.
citation: Pinto AM, Subak LL, Nakagawa S, Vittinghoff E, Wing RR, Kusek JW, Herman WH, West DS, Kuppermann M. The effect of weight loss on changes in health-related quality of life among overweight and obese women with urinary incontinence. Qual Life Res. 2012 Dec;21(10):1685-94. doi: 10.1007/s11136-011-0086-2. Epub 2011 Dec 10.
citation: Pinto AM, Kuppermann M, Nakagawa S, Vittinghoff E, Wing RR, Kusek JW, Herman WH, Subak LL. Comparison and correlates of three preference-based health-related quality-of-life measures among overweight and obese women with urinary incontinence. Qual Life Res. 2011 Dec;20(10):1655-62. doi: 10.1007/s11136-011-9896-5. Epub 2011 Apr 3.
citation: West DS, Gorin AA, Subak LL, Foster G, Bragg C, Hecht J, Schembri M, Wing RR; Program to Reduce Incontinence by Diet and Exercise (PRIDE) Research Group. A motivation-focused weight loss maintenance program is an effective alternative to a skill-based approach. Int J Obes (Lond). 2011 Feb;35(2):259-69. doi: 10.1038/ijo.2010.138. Epub 2010 Aug 3.
citation: Wing RR, Creasman JM, West DS, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise (PRIDE). Improving urinary incontinence in overweight and obese women through modest weight loss. Obstet Gynecol. 2010 Aug;116(2 Pt 1):284-292. doi: 10.1097/AOG.0b013e3181e8fb60.
citation: Wing RR, West DS, Grady D, Creasman JM, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise Group. Effect of weight loss on urinary incontinence in overweight and obese women: results at 12 and 18 months. J Urol. 2010 Sep;184(3):1005-10. doi: 10.1016/j.juro.2010.05.031.
citation: Huang AJ, Subak LL, Wing R, West DS, Hernandez AL, Macer J, Grady D; Program to Reduce Incontinence by Diet and Exercise Investigators. An intensive behavioral weight loss intervention and hot flushes in women. Arch Intern Med. 2010 Jul 12;170(13):1161-7. doi: 10.1001/archinternmed.2010.162.
citation: Subak LL, Wing R, West DS, Franklin F, Vittinghoff E, Creasman JM, Richter HE, Myers D, Burgio KL, Gorin AA, Macer J, Kusek JW, Grady D; PRIDE Investigators. Weight loss to treat urinary incontinence in overweight and obese women. N Engl J Med. 2009 Jan 29;360(5):481-90. doi: 10.1056/NEJMoa0806375.