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
摘要
Pelvic floor disorders encompass several problems resulting from inadequacies in the pelvic floor muscles (PFMs), especially after childbirth. Obstetric anal sphincter injury (OASIS) is a possible complication of vaginal birth that may significantly affect quality of life. Factors related to the pregnant woman, childbirth, and the newborn can increase the risk of developing OASIS.
MethodsThis 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 PFMs 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. The primary outcome will be pelvic floor muscle function assessed using the PERFECT scheme, dynamometry, and surface electromyography. Secondary outcomes will include pelvic floor dysfunction symptoms (Australian Pelvic Floor Questionnaire), self-efficacy, and subjective cure. Data will be analyzed using intention-to-treat principles, with appropriate parametric or non-parametric tests.
DiscussionThis study aims to investigate the effect of PFMs’ training in postpartum women with OASIS on PFMs’ function and pelvic floor disorder symptoms. PFMs’ training is expected to improve PFMs’ 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 PFMs’ training as an intervention for women with OASIS, contributing to improving the quality of life of these patients. This study will provide evidence on the effectiveness of pelvic floor muscle training in postpartum women with OASIS and may contribute to improving clinical management in this population.
Trial registrationBrazilian Registry of Clinical Trials (ReBEC) (registration number: RBR-32z6gw2, registered 4 April 2024). Study protocol version 1.