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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Education, pelvic floor muscle exercises with biofeedback and home exercises.
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Adherence rates
To determine acceptability by assessing adherence to exercises.
Time frame: Baseline to 2-week post-treatment evaluation
Retention rate
To determine feasibility by evaluating attrition.
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in number of urinary leaks
7-day voiding schedule will be used to evaluate the reduction of urinary leakage.
Time frame: Baseline to 2-week post-treatment
Change from baseline in symptoms of pelvic floor dysfunction
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.
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle function
To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle morphometry
To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in sexual function
To explore changes in sexual function (Female Sexual Function Index ranging from 2 to 36), a low score represents a low sexual function.
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Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in quality of life
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.
Time frame: Baseline to 2-week post-treatment evaluation
Patient's global impression of change
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.
Time frame: Baseline to 2-week post-treatment evaluation
Rate of adverse events
To document any adverse events.
Time frame: Baseline to 2-week post-treatment evaluation