Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Study Overview
=================
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.

Official Title
-----------------
Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Behavioral: BF+SUPPORT
* Behavioral: BF+PHONE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with early stage (I-III) prostate cancer. Have completed cancer treatments six months prior. Presence of incontinence symptoms Exclusion Criteria: Receiving hormonal treatment. Urinary tract infection or urinary retention. Cognitive impairment. Having an implant

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A biobehavioral interveniton was tested
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF+SUPPORT<br>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 | Behavioral: BF+SUPPORT<br>* A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).<br>|
| Experimental: BF+PHONE<br>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 | Behavioral: BF+PHONE<br>* A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).<br>|
| No Intervention: Usual Care<br>Subjects continued receiving usual care without receiving any intervention training sessions | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, urinary incontinence, pelvic floor muscle exercise, self-management, behavioral intervention, quality of life