NCT03254355

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

Completed NA Last updated 15 June 2023

What this trial tests

NA trial testing Multimodal physiotherapy in Urinary Incontinence in 126 participants. Completed in 10 May 2023.

Timeline

28 August 2017

Primary endpoint
10 May 2023

10 May 2023

Quick facts

Lead sponsor	Université de Sherbrooke
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	126
Start date	28 August 2017
Primary completion	10 May 2023
Estimated completion	10 May 2023
Sites	1 location across Canada

Drugs / interventions tested

• Multimodal physiotherapy

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →
• Postpartum — all drugs for Postpartum →
• Pelvic Floor; Perineal Rupture, Obstetric — all drugs for Pelvic Floor; Perineal Rupture, Obstetric →
• Physiotherapy — all drugs for Physiotherapy →

Sponsor

Université de Sherbrooke — full company profile →

Who can join

Adults 18 to 45, female only, with Urinary Incontinence or Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.