- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254355
Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion
Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial
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:
- To compare physiotherapy to the control group after treatment and at 9-months after randomization in terms of: a) incontinence and prolapse (objective quantification, symptoms and related impact); b) PFM morphology and function; c) sexual function; d) self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.
- To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral) on the response to physiotherapy treatment on the aforementioned outcomes.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mélanie Morin, pht, PhD
- Phone Number: 13819 819-346-1110
- Email: melanie.m.morin@usherbrooke.ca
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-45 years old
- Postpartum women (≥ 1 vaginal delivery at term (≥ 37 weeks) and ≥ 3 months postpartum
- ≥ 3 urinary incontinence episodes per week over the last 3 months (Symptoms of incontinence must be associated predominantly or solely with stress urinary incontinence (as opposed to urge incontinence) which will be determined with a recommended and validated diagnosis questionnaire (Questionnaire for Urinary Incontinence Diagnosis))
- Women with diagnosis avulsion injury
Exclusion Criteria:
- Pregnancy or postmenopausal
- Previous pelvic irradiation, urogynecological surgery, or PFM physiotherapy after the avulsion occurred
- Significant prolapse (≥3 degree)
- Incontinence due to other causes such as infection, neurological diseases, voiding difficulties
- Any other acute or chronic medical problems likely to interfere with treatment or evaluation such as cancer, chronic constipation (Rome III criteria), obesity (body mass index >35), pacemaker, bladder stimulator
- Medication or ongoing treatment likely to interfere with incontinence
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multimodal physiotherapy
12 weeks of weekly multimodal physiotherapy treatments
|
12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback
|
No Intervention: Waiting-list control group
12 weeks of weekly full-body relaxation massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent reduction in the number of urinary incontinence episodes
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptoms and impact of incontinence and other urogynecological conditions
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
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
|
Change in pelvic floor muscle morphometry and function
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
Evaluated with transperineal ultrasound and dynamometry
|
baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
Change in severity of prolapse
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
Evaluated with POP-Q assessment
|
baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
Change in sexual function
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
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
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
Evaluated with Broom Pelvic Muscle Self-Efficacy Scale
|
baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
Cost analysis
Time Frame: baseline and 9 months after randomization
|
Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI)
|
baseline and 9 months after randomization
|
Treatment satisfaction and impression of change
Time Frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Fractures, Bone
- Wounds and Injuries
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Rupture
- Enuresis
- Fractures, Avulsion
Other Study ID Numbers
- MP-31-2018-1758
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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