To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 1
Healthy Volunteers: f
View:
• Undergone robotic radical prostatectomy
• Able to carry out 1-hour pad test
• Voluntary participation and signing of the informed consent form
Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Shatin
Contact Information
Primary
Chi Fai NG, MD
ngcf@surgery.cuhk.edu.hk
35052625
Time Frame
Start Date: 2022-07-29
Estimated Completion Date: 2026-06
Participants
Target number of participants: 184
Treatments
Active_comparator: Standard of Care
Standard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day
Experimental: EM Chair
Patients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong