N/A
N=279
Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01365182 ↗Enrolled (actual)
279
Serious AEs
1.2%
Results posted
Oct 2022
Primary outcome: Primary: Amount of Urinary Leakage — 23.2; 22.3; 31.5; 11 grams
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BF+SUPPORT (Behavioral); BF+PHONE (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Case Western Reserve University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Urinary Leakage |
23.2; 22.3; 31.5; 11; 23.2; 17.9 | — |
| PRIMARY Frequency of Daily Urinary Leakage |
3.2; 2.9; 2.7; 2.8; 1.8; 1.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01365182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.