Gynecological Pelvic Floor Muscle Training
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01811602|
Recruitment Status : Unknown
Verified April 2015 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : March 14, 2013
Last Update Posted : April 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Other: Training Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
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
- Urinary incontinence [ Time Frame: 12 weeks ]Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary
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): NCT01811602
|Contact: Kristin Campbell, PhDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Kristin Campbell, PhD||University of British Columbia|