Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365182
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : February 18, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amy Zhang, 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.

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 Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Urinary incontinence [ Time Frame: 6 months ]
    Frequency of daily leakage measured on 3-day diary Amount of leakage measured on 1-hour pad test

  2. Quality of Life (QOL) [ Time Frame: 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

  3. Mood [ Time Frame: 6 months ]
    The Profile of Mood States (POMS): subscales of tension, depression and hostility.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365182

Sponsors and Collaborators
Case Western Reserve University
National Cancer Institute (NCI)
Principal Investigator: Amy Zhang, Ph.D. Case Western Reserve University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amy Zhang, Associate Professor, Case Western Reserve University Identifier: NCT01365182     History of Changes
Other Study ID Numbers: CASE 14807
1R01CA127493-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by Amy Zhang, Case Western Reserve University:
prostate cancer
urinary incontinence
pelvic floor muscle exercise
behavioral intervention
quality of life

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders