search
Back to results

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BF+SUPPORT
BF+PHONE
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring prostate cancer, urinary incontinence, pelvic floor muscle exercise, self-management, behavioral intervention, quality of life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    BF+SUPPORT

    BF+PHONE

    Usual Care

    Arm Description

    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

    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

    Subjects continued receiving usual care without receiving any intervention training sessions

    Outcomes

    Primary Outcome Measures

    Amount of Urinary Leakage
    Amount of leakage measured on 1-hour pad test
    Frequency of Daily Urinary Leakage
    Average times of daily leakage measured on a 3-day diary

    Secondary Outcome Measures

    Full Information

    First Posted
    May 26, 2011
    Last Updated
    September 15, 2022
    Sponsor
    Case Western Reserve University
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01365182
    Brief Title
    Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
    Official Title
    Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (Actual)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Case Western Reserve University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence
    Keywords
    prostate cancer, urinary incontinence, pelvic floor muscle exercise, self-management, behavioral intervention, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A biobehavioral interveniton was tested
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    279 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BF+SUPPORT
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    BF+PHONE
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Subjects continued receiving usual care without receiving any intervention training sessions
    Intervention Type
    Behavioral
    Intervention Name(s)
    BF+SUPPORT
    Intervention Description
    A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
    Intervention Type
    Behavioral
    Intervention Name(s)
    BF+PHONE
    Intervention Description
    A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).
    Primary Outcome Measure Information:
    Title
    Amount of Urinary Leakage
    Description
    Amount of leakage measured on 1-hour pad test
    Time Frame
    Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment
    Title
    Frequency of Daily Urinary Leakage
    Description
    Average times of daily leakage measured on a 3-day diary
    Time Frame
    Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy Zhang, Ph.D.
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19917835
    Citation
    Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, Buzaid AC, Cochran AJ, Coit DG, Ding S, Eggermont AM, Flaherty KT, Gimotty PA, Kirkwood JM, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sober AJ, Sondak VK. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009 Dec 20;27(36):6199-206. doi: 10.1200/JCO.2009.23.4799. Epub 2009 Nov 16.
    Results Reference
    background
    PubMed Identifier
    3558716
    Citation
    Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
    Results Reference
    background
    PubMed Identifier
    26231554
    Citation
    Zhang AY, Bodner DR, Fu AZ, Gunzler DD, Klein E, Kresevic D, Moore S, Ponsky L, Purdum M, Strauss G, Zhu H. Effects of Patient Centered Interventions on Persistent Urinary Incontinence after Prostate Cancer Treatment: A Randomized, Controlled Trial. J Urol. 2015 Dec;194(6):1675-81. doi: 10.1016/j.juro.2015.07.090. Epub 2015 Jul 29.
    Results Reference
    result
    PubMed Identifier
    27341843
    Citation
    Zhang AY, Fu AZ, Moore S, Zhu H, Strauss G, Kresevic D, Klein E, Ponsky L, Bodner DR. Is a behavioral treatment for urinary incontinence beneficial to prostate cancer survivors as a follow-up care? J Cancer Surviv. 2017 Feb;11(1):24-31. doi: 10.1007/s11764-016-0557-0. Epub 2016 Jun 24.
    Results Reference
    result
    PubMed Identifier
    30903368
    Citation
    Zhang AY, Ganocy S, Fu AZ, Kresevic D, Ponsky L, Strauss G, Bodner DR, Zhu H. Mood outcomes of a behavioral treatment for urinary incontinence in prostate cancer survivors. Support Care Cancer. 2019 Dec;27(12):4461-4467. doi: 10.1007/s00520-019-04745-w. Epub 2019 Mar 22.
    Results Reference
    result
    PubMed Identifier
    31762400
    Citation
    Zhang AY, Burant C, Fu AZ, Strauss G, Bodner DR, Ponsky L. Psychosocial mechanisms of a behavioral treatment for urinary incontinence of prostate cancer survivors. J Psychosoc Oncol. 2020 Mar-Apr;38(2):210-227. doi: 10.1080/07347332.2019.1678547. Epub 2019 Nov 24.
    Results Reference
    result
    PubMed Identifier
    25963381
    Citation
    Zhang AY, Fu AZ. Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients. Psychooncology. 2016 Apr;25(4):421-7. doi: 10.1002/pon.3849. Epub 2015 May 12.
    Results Reference
    result

    Learn more about this trial

    Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

    We'll reach out to this number within 24 hrs