Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy Zhang, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01365182
First received: May 26, 2011
Last updated: February 16, 2015
Last verified: February 2015
  Purpose

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 Intervention Phase
Urinary Incontinence
Behavioral: BF+SUPPORT
Behavioral: BF+PHONE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Urinary incontinence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Frequency of daily leakage measured on 3-day diary Amount of leakage measured on 1-hour pad test

  • Quality of Life (QOL) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Profile of Mood States (POMS): subscales of tension, depression and hostility.


Enrollment: 279
Study Start Date: January 2009
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365182

Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Amy Zhang, Ph.D. Case Western Reserve University
  More Information

No publications provided

Responsible Party: Amy Zhang, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01365182     History of Changes
Other Study ID Numbers: CASE 14807, 1R01CA127493-01A2
Study First Received: May 26, 2011
Last Updated: February 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
prostate cancer
urinary incontinence
pelvic floor muscle exercise
self-management
behavioral intervention
quality of life

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

ClinicalTrials.gov processed this record on May 21, 2015