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Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion

NCT03254355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Multimodal physiotherapy

12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Université de Sherbrooke

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2023-05-10
Completion
2023-05-10

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254355 on ClinicalTrials.gov