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OpenTrials
Completed

NCT Number: NCT01365182

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BF+SUPPORT

Behavioral

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

A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).

Primary outcomes

  1. Amount of Urinary Leakage

    Time frame: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment

    Amount of leakage measured on 1-hour pad test

  2. Frequency of Daily Urinary Leakage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jun 3, 2011
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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