Clinical trial NCT03254355: Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion
Official title: Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Postpartum
Pelvic Floor; Perineal Rupture, Obstetric
Physiotherapy
Keywords: avulsion injury
urinary incontinence
multimodal physiotherapy
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-08-18
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent reduction in the number of urinary incontinence episodes
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Secondary outcomes:
measure: Change in symptoms and impact of incontinence and other urogynecological conditions
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
measure: Change in pelvic floor muscle morphometry and function
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
measure: Change in severity of prolapse
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
measure: Change in sexual function
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
measure: Change in self-efficacy
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
measure: Cost analysis
timeFrame: baseline and 9 months after randomization
measure: Treatment satisfaction and impression of change
timeFrame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
References: