An interventional study of Multimodal physiotherapy in Urinary Incontinence, Postpartum and Pelvic Floor; Perineal Rupture, Obstetric, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
12 weeks of weekly multimodal physiotherapy treatments
Procedure: Multimodal physiotherapy
12 weeks of weekly full-body relaxation massage
12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback
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
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
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)
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in pelvic floor muscle morphometry and function
Evaluated with transperineal ultrasound and dynamometry
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in severity of prolapse
Evaluated with POP-Q assessment
Time frame: 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)
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in self-efficacy
Evaluated with Broom Pelvic Muscle Self-Efficacy Scale
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Cost analysis
Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI)
Time frame: 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)
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke