Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improving Urinary Continence and Quality of Life in Prostate Cancer Patients|
- Urinary incontinence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Frequency of daily leakage measured on 3-day diary Amount of leakage measured on 1-hour pad test
- Quality of Life (QOL) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The International Prostate Symptom Score (IPSS) University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) Visual Analogue Scale (VAS)
SF36 EQ-5D Index
- Mood [ Time Frame: 6 months ] [ Designated as safety issue: No ]The Profile of Mood States (POMS): subscales of tension, depression and hostility.
|Study Start Date:||January 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).
|No Intervention: Usual Care|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365182
|Principal Investigator:||Amy Zhang, Ph.D.||Case Western Reserve University|