Study of High-Intensity Focused Electromagnetic HIFEM Technology Versus Standard Care for Stress Urinary Incontinence in Chinese Men After Robotic Prostate Surgery

What this Trial Is About

Researchers are evaluating the use of High-Intensity Focused Electromagnetic HIFEM Technology for treating stress urinary incontinence in Chinese men who have undergone robotic radical prostatectomy. This study is a prospective, randomized trial comparing the safety and effectiveness of HIFEM technology combined with pelvic floor exercises against the standard care approach. The goal is to determine if adding HIFEM-assisted training improves urinary control after prostate surgery. Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes perioperative education and advice to perform pelvic floor exercises at least 30 times daily. The other group will receive six sessions of HIFEM-assisted pelvic floor muscle training using the BTL EMsella device, each session lasting 30 minutes with modulated intensity, plus the standard care. This intervention will start within two weeks after the removal of the Foley catheter. Follow-up visits will occur at 1, 3, and 6 months after surgery. During the study, participants will undergo assessments including a 1-hour pad test to measure urine leakage at baseline and at 1, 3, and 6 months post-treatment. Other evaluations include measuring the severity of incontinence, sexual function, and monitoring for complications at the same time points. This trial aims to provide detailed information on how well the treatments control urinary incontinence and their safety over a six-month period.

Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy