NCT01365182

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2022

Completed
Last Updated

October 12, 2022

Status Verified

September 1, 2022

Enrollment Period

3.9 years

First QC Date

May 26, 2011

Results QC Date

December 18, 2021

Last Update Submit

September 15, 2022

Conditions

Urinary Incontinence

Keywords

prostate cancerurinary incontinencepelvic floor muscle exerciseself-managementbehavioral interventionquality of life

Outcome Measures

Primary Outcomes (2)

  • Amount of Urinary Leakage

    Amount of leakage measured on 1-hour pad test

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

  • Frequency of Daily Urinary Leakage

    Average times of daily leakage measured on a 3-day diary

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

Study Arms (3)

BF+SUPPORT

EXPERIMENTAL

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

Behavioral: BF+SUPPORT

BF+PHONE

EXPERIMENTAL

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

Behavioral: BF+PHONE

Usual Care

NO INTERVENTION

Subjects continued receiving usual care without receiving any intervention training sessions

Interventions

BF+SUPPORTBEHAVIORAL

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

BF+SUPPORT
BF+PHONEBEHAVIORAL

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

BF+PHONE

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been diagnosed with early stage (I-III) prostate cancer.
  • Have completed cancer treatments six months prior.
  • Presence of incontinence symptoms

You may not qualify if:

  • Receiving hormonal treatment.
  • Urinary tract infection or urinary retention.
  • Cognitive impairment.
  • Having an implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 19917835BACKGROUND

  • 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.

    PMID: 3558716BACKGROUND

  • 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.

    PMID: 26231554RESULT

  • 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.

    PMID: 27341843RESULT

  • 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.

    PMID: 30903368RESULT

  • 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.

    PMID: 31762400RESULT

  • 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.

    PMID: 25963381RESULT

MeSH Terms

Conditions

Urinary IncontinenceProstatic Neoplasms

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesProstatic Diseases

Limitations and Caveats

Limitations: * The rate of missing data at 6 months was higher for daily leakage frequency than the leakage amount. * The 3-month intervention duration limited our ability to assess intervention sustainability and long-term effect.

Results Point of Contact

Title
Amy Zhang PhD
Organization
Case Western Reserve University
amy.zhang@case.edu
2163680968

Study Officials

  • Amy Zhang, Ph.D.

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A biobehavioral interveniton was tested
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 3, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

October 12, 2022

Results First Posted

October 12, 2022

Record last verified: 2022-09