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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led to the discovery of this previously unknown major injury and further research now enables its diagnosis with readily available techniques. Avulsion injury has alarming consequences because it has been associated with a higher rate of urinary incontinence in the postpartum period as well as the long-term development of other major urogynecological conditions such as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from severe symptoms with significant related impacts on physical activities, overall well-being and quality of life, but they also present a higher rate of surgical failures. Moreover, it is still unknown whether the most recommended first-line treatment for urinary incontinence -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot study conducted by our team supports the rationale and the efficacy of physiotherapy for improving PFM function in women with avulsion, despite their major muscle injury.
Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in women with avulsion at 9-months after randomization compared to a waiting-list control group.
Secondary objectives:
This is a multicenter randomized controlled trial using a parallel group design that involves women with a confirmed diagnosis of avulsion and suffering from urinary incontinence. Participants will be randomized into either physiotherapy or a waiting-list control group. Both groups will be evaluated at baseline, post-treatment (3 months post-randomization) and 9 months after randomization. Women in the control group will receive full-body relaxation massage which has shown no effect on continence but was selected to control for effects of attention received by the therapist. After the 9-month assessment, women assigned to the control group will receive the same physiotherapy treatment and undergo a last assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal physiotherapy | Experimental | 12 weeks of weekly multimodal physiotherapy treatments |
|
| Waiting-list control group | No Intervention | 12 weeks of weekly full-body relaxation massage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal physiotherapy | Procedure | 12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback |
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in the number of urinary incontinence episodes | The 7-day bladder diary was selected as the primary outcome to measure urinary leakage reduction | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms and impact of incontinence and other urogynecological conditions | Evaluated with ICI Modular Questionnaires (ICIQ), Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ-SF) and Pelvic Organ Prolapse Symptom score (POP-SS) | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D000071562 | Fractures, Avulsion |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Change in pelvic floor muscle morphometry and function | Evaluated with transperineal ultrasound and dynamometry | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
| Change in severity of prolapse | Evaluated with POP-Q assessment | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
| Change in sexual function | Evaluated with Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-SF) | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
| Change in self-efficacy | Evaluated with Broom Pelvic Muscle Self-Efficacy Scale | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
| Cost analysis | Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI) | baseline and 9 months after randomization |
| Treatment satisfaction and impression of change | Evaluated with Patient Satisfaction Questionnaire (PSQ) and Patient's Global Impression of Change (PGIC) | baseline, post-treatment (3 months post-randomization) and 9 months after randomization |
| 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 |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |