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NCT Number: NCT03254355

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fractures, Avulsion Fractures, Bone Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor; Perineal Rupture, Obstetric Physiotherapy Postpartum Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. Change in severity of prolapse

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

    Evaluated with POP-Q assessment

  4. 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)

  5. 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

  6. Cost analysis

    Time frame: baseline and 9 months after randomization

    Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI)

  7. 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)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2017
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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