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

NCT03254355 | Completed

• 1 other identifier: MP-31-2018-1758
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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. 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. 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

Urinary Incontinence; Postpartum; Pelvic Floor; Perineal Rupture, Obstetric; Physiotherapy

Keywords

avulsion injury; urinary incontinence; multimodal physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in symptoms and impact of incontinence and other urogynecological conditions

  baseline, post-treatment (3 months post-randomization) and 9 months after randomization

• Change in pelvic floor muscle morphometry and function

  baseline, post-treatment (3 months post-randomization) and 9 months after randomization

• Change in severity of prolapse

  baseline, post-treatment (3 months post-randomization) and 9 months after randomization

• Change in sexual function

  baseline, post-treatment (3 months post-randomization) and 9 months after randomization

• Change in self-efficacy

  baseline, post-treatment (3 months post-randomization) and 9 months after randomization

Study Arms (2)

Multimodal physiotherapy

EXPERIMENTAL

12 weeks of weekly multimodal physiotherapy treatments

Procedure: Multimodal physiotherapy

Waiting-list control group

NO INTERVENTION

12 weeks of weekly full-body relaxation massage

Interventions

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

Multimodal physiotherapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence; Fractures, Avulsion

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Associate Professor

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 18, 2017
• Study Start: August 28, 2017
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CA (1)