Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01365182|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Behavioral: BF+SUPPORT Behavioral: BF+PHONE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||279 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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|
- Urinary incontinence [ Time Frame: 6 months ]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 ]
The International Prostate Symptom Score (IPSS) University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) Visual Analogue Scale (VAS)
SF36 EQ-5D Index
- Mood [ Time Frame: 6 months ]The Profile of Mood States (POMS): subscales of tension, depression and hostility.
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 ClinicalTrials.gov identifier (NCT number): NCT01365182
|Principal Investigator:||Amy Zhang, Ph.D.||Case Western Reserve University|