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

Université de Sherbrooke

Status

Completed

Conditions

Physiotherapy

Pelvic Floor; Perineal Rupture, Obstetric

Postpartum

Urinary Incontinence

Treatments

Procedure: Multimodal physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03254355

MP-31-2018-1758

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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