Gynecologic Cancer, Urinary Incontinence
Conditions
Keywords
Pilot study, Gynecological cancer survivors, Urinary Incontinence, Physiotherapy
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.
Interventions
OTHERPhysiotherapy
Education, pelvic floor muscle exercises with biofeedback and home exercises.
Sponsors
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Institut Universitaire de Gériatrie de Montréal
Jewish General Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rates | Baseline to 2-week post-treatment evaluation | To determine acceptability by assessing adherence to exercises. |
| Retention rate | Baseline to 2-week post-treatment evaluation | To determine feasibility by evaluating attrition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pelvic floor muscle function | 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 | 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 | 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 number of urinary leaks | Baseline to 2-week post-treatment | 7-day voiding schedule will be used to evaluate the reduction of urinary leakage. |
| Patient's global impression of change | 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 | Baseline to 2-week post-treatment evaluation | To document any adverse events. |
| Change from baseline in quality of life | 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. |
| Change from baseline in symptoms of pelvic floor dysfunction | 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. |
Countries
Canada
Outcome results
None listed