Objective: To evaluate outcomes after pelvic floor muscle therapy, as compared with perineorrhaphy and distal posterior colporrhaphy, in the treatment of women with a poorly healed second-degree obstetric injury diagnosed at least 6 months postpartum.
Methods: We performed a single center, open-label, randomized controlled trial. After informed consent, patients with a poorly healed second-degree perineal tear at minimum 6 months postpartum were randomized to either surgery or physical therapy. The primary outcome was treatment success, as defined by Patient Global Impression of Improvement, at 6 months. Secondary outcomes included the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the Hospital Anxiety and Depression Scale. Assuming a 60% treatment success in the surgery group and 20% in the physical therapy group, plus anticipating a 20% loss to follow-up, a total of 70 patients needed to be recruited.
Results: From October 2015 to June 2018, 70 of 109 eligible patients were randomized, half into surgery and half into tutored pelvic floor muscle therapy. The median age of the study group was 35 years, and the median duration postpartum at enrollment in the study was 10 months. There were three dropouts in the surgery group postrandomization. In an intention-to-treat analysis, with worst case imputation of missing outcomes, subjective global improvement was reported by 25 of 35 patients (71%) in the surgery group compared with 4 of 35 patients (11%) in the physical therapy group (treatment effect in percentage points 60% [95% CI 42-78%], odds ratio 19 [95% CI 5-69]). The surgery group was superior to physical therapy regarding all secondary endpoints.
Conclusion: Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum.
Clinical trial registration: ClinicalTrials.gov, NCT02545218.