Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT03957434|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Cancer Urinary Incontinence||Other: Physiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||October 16, 2021|
|Estimated Study Completion Date :||October 16, 2021|
12-weekly physiotherapy treatment sessions.
Education, pelvic floor muscle exercises with biofeedback and home exercises.
Other Name: Pelvic floor rehabilitation
No Intervention: Standard usual care
Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.
- Adherence rates [ Time Frame: Baseline to 2-week post-treatment evaluation ]To determine acceptability by assessing adherence to exercises.
- Retention rate [ Time Frame: Baseline to 2-week post-treatment evaluation ]To determine feasibility by evaluating attrition.
- Change from baseline in number of urinary leaks [ Time Frame: Baseline to 2-week post-treatment ]7-day voiding schedule will be used to evaluate the reduction of urinary leakage.
- Change from baseline in symptoms of pelvic floor dysfunction [ Time Frame: Baseline to 2-week post-treatment evaluation ]To explore changes in pelvic floor symptoms (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ranging from 0 to 21), a high score represents high pelvic floor symptoms.
- Change from baseline in pelvic floor muscle function [ Time Frame: Baseline to 2-week post-treatment evaluation ]To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).
- Change from baseline in pelvic floor muscle morphometry [ Time Frame: Baseline to 2-week post-treatment evaluation ]To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).
- Change from baseline in sexual function [ Time Frame: Baseline to 2-week post-treatment evaluation ]To explore changes in sexual function (Female Sexual Function Index ranging from 2 to 36), a low score represents a low sexual function.
- Change from baseline in quality of life [ Time Frame: Baseline to 2-week post-treatment evaluation ]To explore changes in quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ranging from 0 to 100), a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life represents a high quality of life and a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Patient's global impression of change [ Time Frame: Baseline to 2-week post-treatment evaluation ]To determine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
- Rate of adverse events [ Time Frame: Baseline to 2-week post-treatment evaluation ]To document any adverse events.
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): NCT03957434
|Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Ma Guixiang Nadeau, PT 819-346-1110 ext 18439 email@example.com|
|Principal Investigator: Mélanie Morin, PT, PhD|
|Sub-Investigator: Marie-Pierre Cyr, PT, MSc|