Pelvic Floor Workout for Preventing Stress Urinary Incontinence in Primiparous Women: A Randomized Clinical Trial.

Importance: Rehabilitation training methods for stress urinary incontinence (SUI) need to be based on a global postural exercise, involving overall core muscle strength, core stability, and balance of the pelvis and spine. The pelvic floor workout (PEFLOW) program was developed to promote in-pregnancy pelvic floor muscle training to prevent postpartum SUI. Objective: To assess the effectiveness of PEFLOW in preventing postpartum SUI. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted across 9 hospitals in China. Eligibility criteria were primiparous women aged 20 to 40 years, with singleton pregnancy of less than 16 weeks' gestation, and who visited the outpatient obstetric department of 1 of the 9 hospitals from August 1, 2020, to June 6, 2022. Participants, who were followed up through January 17, 2024, were randomly assigned to the exercise group or the control group and were followed up at 37 weeks' gestation and 6 weeks, 3 months, 6 months, and 12 months post partum. Primiparous women with severe complications; SUI or pelvic organ prolapse; and/or a history of cervical insufficiency, recurrent miscarriage, or induced labor were excluded. Intention-to-treat (ITT) analysis was conducted between May 1 and July 1, 2024. Intervention: Participants in the exercise group were trained to practice PEFLOW from 28 weeks' gestation to delivery, with checkups and guidance provided every 2 weeks. Participants in the control group were provided usual medical care. Main Outcome and Measure: The primary outcome was the incidence of SUI at 6 weeks post partum among participants in the exercise and control groups. SUI was diagnosed based on urinary leakage when abdominal pressure increased or detected from a stress test. Symptomatic SUI and the Modified Oxford Scale (MOS) score were recorded. Results: A total of 764 women (median [IQR] age, 29 [27-32] years) were randomized into the exercise group (n = 382) and the control group (n = 382). ITT analysis showed that the incidence of SUI at 6 weeks post partum was significantly lower in the exercise group than the control group (8.7% [32 of 367] vs 13.9% [50 of 360]), with a risk difference of 5.17 (95% CI, 0.36-10.03) percentage points (P = .03). The proportion of women with an MOS score of 4 or higher at 6 weeks post partum was significantly higher in the exercise group than the control group (17.8% [68 of 382] vs 7.9% [30 of 382]), with a risk difference of 9.95 (95% CI, 5.05-14.87) percentage points (P < .001). Conclusions and Relevance: In this multicenter randomized clinical trial, PEFLOW effectively reduced SUI incidence at 6 weeks post partum. This finding suggests that PEFLOW is effective in preventing SUI in pregnancy. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000029618.