Comparison of 90-90 ball and balloon exercise versus Kegel's exercise on pelvic floor muscle strength and quality of life among postpartum women with stress urinary incontinence-a randomized clinical trial protocol.

BACKGROUND: Stress urinary incontinence (SUI) is one of the notable problems in postpartum women. Even though Kegel's exercise (KE) is a universally followed pelvic floor exercise for SUI, it is tough to perform as patients find it hard to identify the correct tiny muscles to contract. Co-contraction of the pelvic diaphragm during 90-90 ball balloon exercises (BBE) will work against IAP, and that produces a more controlled action of pelvic floor muscles. This study aims to compare the effectiveness of 90-90 BBE vs. KE over pelvic floor muscle strength (PFMS) and quality of life (QoL) in women with postpartum SUI. METHOD: Eighty-six postpartum women with SUI will be screened and recruited through purposive sampling. Subjects will be divided into experimental and control groups through block randomization. The control group will receive KE along with the Knack technique (KT); meanwhile, the experimental group will receive 90/90 BBE with KT (10 repetitions, 3 sets a day, 3 days a week, 8 weeks). Outcome measures are pelvic floor muscle strength (PFMS), quality of life, 1-h pad test, and global rate of change, which will be taken at pre- and post-intervention at the 8th week, 3rd month, and 6th month follow-up. Parametric or nonparametric statistical tests will be used based on the normal distribution of data. The result will be presented in the form of a 95% confidence interval and P value. DISCUSSION: This trial will provide novel evidence comparing a commonly used exercise (Kegel's) with the 90-90 ball and balloon exercise, a physiologically guided approach targeting pelvic floor-abdominal synergy. If effective, this intervention may offer an easier and potentially more acceptable alternative to postpartum women with stress urinary incontinence. However, the interpretation of findings should consider that the sample size estimation was based on pre-post data, which may overestimate the true effect. CLINICAL TRIAL REGISTRATION: CTRI-Clinical Trial Registry of India (ICMR)-Reg.No: CTRI/2024/06/069047. Trial registered prospectively. Registered on 18.06.2024.