Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors with Urinary Incontinence
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gynecologic Cancer
- Sponsor
- Université de Sherbrooke
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Adherence rates
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study.
Detailed Description
Epidemiological studies demonstrated a growing number of gynecological cancer survivors, and this population is at great risk of developing pelvic floor dysfunction after cancer and its treatment. Representing the most prevalent pelvic floor dysfunction, urinary incontinence affects up to 70% of gynecological cancer survivors. International practice guidelines, in line with available meta-analysis, recommend physiotherapy as a first-line treatment to reduce urinary incontinence. However, there is limited evidence on its effectiveness in gynecological cancer survivors. Considering the current knowledge and the negative impacts of urinary incontinence, there is an urgent need to examine whether this population can benefit from this intervention in a pilot study, to conduct eventually a larger randomized controlled trial. The objectives of the present study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence. A total of 44 participants will be randomized to receive either physiotherapy or standard usual care (wait-list for physiotherapy). Baseline and post-treatment evaluations will be realized by a physiotherapist.
Investigators
Mélanie Morin
Researcher and Associate Professor
Université de Sherbrooke
Eligibility Criteria
Inclusion Criteria
- •History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
- •Scheduled oncological treatments completed
- •Stress or mixed urinary incontinence with a frequency of at least three urinary leakage per
Exclusion Criteria
- •Pelvic floor rehabilitation in the last year
- •Other conditions interfering with assessment
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change from baseline in pelvic floor muscle morphometry(Baseline to 2-week post-treatment evaluation)
- Change from baseline in symptoms of pelvic floor dysfunction(Baseline to 2-week post-treatment evaluation)
- Change from baseline in pelvic floor muscle function(Baseline to 2-week post-treatment evaluation)
- Change from baseline in number of urinary leaks(Baseline to 2-week post-treatment)
- Change from baseline in sexual function(Baseline to 2-week post-treatment evaluation)
- Change from baseline in quality of life(Baseline to 2-week post-treatment evaluation)
- Patient's global impression of change(Baseline to 2-week post-treatment evaluation)
- Rate of adverse events(Baseline to 2-week post-treatment evaluation)