NCT01365182

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.

Detailed description

This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	BF+SUPPORT	A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
BEHAVIORAL	BF+PHONE	A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2011-06-03
• Last updated: 2022-10-12
• Results posted: 2022-10-12