Clinical trial NCT03957434: Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
Official title: Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Urinary Incontinence
Keywords: Pilot study
Gynecological cancer survivors
Urinary Incontinence
Physiotherapy
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Institut Universitaire de Gériatrie de Montréal
name: Jewish General Hospital
name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2019-05-21
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence rates
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Retention rate
timeFrame: Baseline to 2-week post-treatment evaluation
Secondary outcomes:
measure: Change from baseline in number of urinary leaks
timeFrame: Baseline to 2-week post-treatment
measure: Change from baseline in symptoms of pelvic floor dysfunction
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change from baseline in pelvic floor muscle function
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change from baseline in pelvic floor muscle morphometry
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change from baseline in sexual function
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change from baseline in quality of life
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Patient's global impression of change
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Rate of adverse events
timeFrame: Baseline to 2-week post-treatment evaluation
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
References: