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Improving Continence and Quality of Life in Prostate Cancer Patients


Phase 3
21 Years
N/A
Open (Enrolling)
Male
Urinary Incontinence, Mood

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Trial Information

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.


Inclusion Criteria:



1. stage I, II and III prostate cancer;

2. having completed treatment (surgery or radiation) at least six months prior;

3. presence of UI symptoms.

Exclusion Criteria:

1. receiving hormonal treatment

2. urinary tract infection or urinary retention

3. cognitive impairment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Urinary incontinence

Outcome Description:

Urinary incontinence is measured in the amount and frequency of urinary leakage

Outcome Time Frame:

Change from baseline in urinary incontinence at 6 months

Safety Issue:

No

Principal Investigator

Amy Zhang, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Institutional Review Board

Study ID:

1R01CA127493-01A2

NCT ID:

NCT01365182

Start Date:

January 2009

Completion Date:

December 2012

Related Keywords:

  • Urinary Incontinence
  • Mood
  • prostate cancer
  • urinary incontinence
  • pelvic floor muscle exercise
  • self-management
  • behavioral intervention
  • quality of life
  • Prostatic Neoplasms
  • Urinary Incontinence

Name

Location
Case Comprehensive Cancer Center (UHCMC, CCF, MetroHealth) Cleveland, Ohio  44106