Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Sponsor

Case Western Reserve University (Other)

Overall Status

Completed

CT.gov ID

NCT01365182

Collaborator

National Cancer Institute (NCI) (NIH)

279

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Behavioral: BF+SUPPORT Behavioral: BF+PHONE	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

279 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: BF+SUPPORT	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).
Other: BF+PHONE	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).
No Intervention: Usual Care

Arm

Intervention/Treatment

Other: BF+SUPPORT

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).

Other: BF+PHONE

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).

No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

Urinary incontinence [6 months]
Frequency of daily leakage measured on 3-day diary Amount of leakage measured on 1-hour pad test
Quality of Life (QOL) [6 months]
The International Prostate Symptom Score (IPSS) University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) Visual Analogue Scale (VAS) Health-related QOL: SF36 EQ-5D Index
Mood [6 months]
The Profile of Mood States (POMS): subscales of tension, depression and hostility.