Effects of individualized physiotherapeutic interventions on functioning and health in postpartum women who have suffered a levator ani muscle injury. A pilot randomized controlled trial

Background: The levator ani muscle (LAM) has a central role in pelvic organ support and maintaining urinary and fecal continence. It is unclear if women with levator ani muscle injuries (LAI) due to vaginal delivery respond to pelvic floor muscle physiotherapy. This pilot randomized controlled trial (RCT) will evaluate an individualized physiotherapy program in primiparous women, who have known risk factors for LAI, after simplex vaginal delivery. Methods This pilot RCT is currently recruiting at three hospitals in the Västra Götaland County in Sweden (expected enrollment n = 78). The main objective is to demonstrate clinical trial feasibility, including the feasibility and acceptability of randomizing the intervention and collection of outcome measures. Women with LAI diagnosed based on three-dimensional (3D) transperineal ultrasound 10–12 weeks after delivery will be randomized to receive individualized physiotherapy (intervention) or standard care (control). Women without LAI will comprise a third arm. Individualized physiotherapy will be tailored based on patient needs, clinical findings, and symptoms starting at 3 months postpartum to approximately 1 year. Standard care will follow regional postpartum guidelines. The study will evaluate pelvic floor muscle morphometry by 3D transperineal ultrasound and the Pelvic Organ Prolapse Quantification Examination (POP-Q) at 3 and 12 months. Patient-reported urogynecological symptoms, sexual function, and fear-avoidance beliefs will be assessed using validated questionnaires at 3, 6, and 12 months. Discussion Individualized pelvic floor physiotherapy regimens have the potential to alleviate symptoms and improve the quality of life of women with LAI, which have a considerable personal, societal, and health economic impact. The findings of the study will serve as the basis for a larger-scale multicenter RCT. Trial registration: ClinicalTrials.gov, Unique Protocol ID: 278806, NCT05617092, on November 15, 2022.