Gynecological Pelvic Floor Muscle Training
A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study|
- Urinary incontinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction
The participants randomized to the pelvic floor muscle training intervention will receive pelvic floor muscle training (0-12 weeks) delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction. The intervention is 9 individual, one-on-one, 45-minute sessions; weekly for weeks 0-6 and bi-weekly for weeks 7-12 (first session will be 60 minutes). The sessions will provide pelvic floor muscle training based on the latest evidence, including biofeedback, to teach the correct technique for pelvic floor contractions, and participants will be asked to complete daily pelvic floor exercises at home.
Other Name: Pelvic Floor Muscle Training
Usual Care Control
Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.
Other: Usual Care
The participants randomized to the educational pamphlet intervention (usual care control) will receive a 1-page sheet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.
Other Name: Educational pamphlet
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811602
|Contact: Kristin Campbell, PhDemail@example.com|
|Contact: Sarah Finlayson||604-877-6000 ext 2367||Sarah.Finlayson@vch.ca|
|Canada, British Columbia|
|Women's Health Centre||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Contact: Pat Lieblich, PT firstname.lastname@example.org|
|Principal Investigator:||Kristin Campbell, PhD||University of British Columbia|