Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Behavioral: BF+PHONE; Behavioral: BF+SUPPORT

• Registration Number: NCT01365182
• Lead Sponsor: Case Western Reserve University

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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Results First Submitted: 2021-12-18
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Results First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 279

Inclusion Criteria

1. Have been diagnosed with early stage (I-III) prostate cancer.
2. Have completed cancer treatments six months prior.
3. Presence of incontinence symptoms

Exclusion Criteria

1. Receiving hormonal treatment.
2. Urinary tract infection or urinary retention.
3. Cognitive impairment.
4. Having an implant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BF+PHONE	BF+PHONE	a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills
BF+SUPPORT	BF+SUPPORT	a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills

Primary Outcome Measures

Name	Time	Method
Amount of Urinary Leakage	Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment	Amount of leakage measured on 1-hour pad test
Frequency of Daily Urinary Leakage	Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment	Average times of daily leakage measured on a 3-day diary