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| Name | Class |
|---|---|
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
| Institut Universitaire de Gériatrie de Montréal | OTHER |
| Jewish General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy | Experimental | 12-weekly physiotherapy treatment sessions. |
|
| Standard usual care | No Intervention | Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapy | Other | Education, pelvic floor muscle exercises with biofeedback and home exercises. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rates | To determine acceptability by assessing adherence to exercises. | Baseline to 2-week post-treatment evaluation |
| Retention rate | To determine feasibility by evaluating attrition. | Baseline to 2-week post-treatment evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in number of urinary leaks | 7-day voiding schedule will be used to evaluate the reduction of urinary leakage. | Baseline to 2-week post-treatment |
| Change from baseline in symptoms of pelvic floor dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Centre hospitalier de l'Université de Montréal (CHUM) |
| OTHER |
Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
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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.
| 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). | 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). | 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. | 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. | 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. | Baseline to 2-week post-treatment evaluation |
| Rate of adverse events | To document any adverse events. | Baseline to 2-week post-treatment evaluation |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |