Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion
Condition: Urinary Incontinence; Postpartum; Pelvic Floor; Perineal Rupture, Obstetric; Physiotherapy
MeSH terms: Urinary Incontinence; Enuresis; Rupture; Fractures, Avulsion
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Multimodal physiotherapy
Intervention type(s): Procedure
Intervention description(s): 12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: avulsion injury; urinary incontinence; multimodal physiotherapy