Effect of Pelvic Floor Muscle Training on Pelvic Floor Muscle Function and Symptoms of Dysfunction in Women Post Obstetric Anal Sphincter Injury (Oasis): Study Protocol for a Randomized Controlled Trial

Abstract Background: Pelvic floor disorders encompass several problems resulting from inadequacies in the pelvic floor muscles (PFM), especially after childbirth. Obstetric Anal Sphincter Injury (OASIS) is a complication of vaginal birth that can significantly affect the quality of life of these women. Factors related to the pregnant woman, childbirth, and the newborn can increase the risk of developing OASIS. The primary physical therapy intervention for pelvic floor disorders is PFM training, created by Kegel in 1948. Methods: This study encompasses a prospective, randomized clinical trial design with parallel groups. Women diagnosed with OASIS are recruited within 60 days of giving birth. The control group receives standard postpartum care, and the intervention group receives standard care plus a PFM training program for 12 weeks. Participants are assessed in three in-person and two online sessions throughout the study. The study is conducted at a single center. Discussion: This study aims to investigate the effect of PFM training in postpartum women with OASIS on PFM function and pelvic floor disorder symptoms. PFM training is expected to improve PFM function, reduce pelvic floor disorder symptoms, and provide an effective therapeutic option for postpartum women with anal sphincter injuries. This study provides significant results on the effectiveness of PFM training as an intervention for women with OASIS, contributing to improving the quality of life of these patients. This research protocol aims to fill a gap in scientific knowledge regarding the treatment of women with OASIS by providing solid evidence on the effectiveness of PFM training in this specific population. Trial registration: Brazilian Registry of Clinical Trials (ReBEC) (registration number: RBR-32z6gw2, registered 4 April 2024). Study protocol version 1.