Improving Continence and Quality of Life in Prostate Cancer Patients
Study participants will be randomly assigned to one of three study arms: (1) biofeedback
PFME plus a support group (BF+GROUP); (2) biofeedback PFME plus telephone (BF+PHONE); and
(3) usual care (UC). The BF+GROUP and BF+PHONE participants will learn PFME through
computerized biofeedback. Thereafter, the BF+GROUP participants will attend six group
meetings and the BF+PHONE participants will have six phone contacts every other week for
three months. The interventions use a Problem-Solving Therapy (PST) framework to treat UI.
The UC participants will not receive biofeedback PFME or telephone/group intervention but
will continue receiving usual medical care. In addition, 51 moderately to severely
incontinent patients will be recruited from the three study groups, with 17 per group, to
undergo urodynamic testing at T1 and T2. Data of the costs for the interventions and the
participants' medical care will be collected for a cost-effectiveness analysis.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Urinary incontinence is measured in the amount and frequency of urinary leakage
Change from baseline in urinary incontinence at 6 months
Amy Zhang, Ph.D.
Case Western Reserve University
United States: Institutional Review Board
|Case Comprehensive Cancer Center (UHCMC, CCF, MetroHealth)||Cleveland, Ohio 44106|