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.
Undergone robotic radical prostatectomy
Able to carry out 1-hour pad test
Voluntary participation and signing of the informed consent form
Pre-existing stress urinary incontinence
Post-void residual urine greater than 200ml
Active urinary tract infection
Urethral or bladder fistula
Parallel
EM Chair
DevicePatients 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.
Standard of care
Other interventionStandard 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
Weight of 1-hour pad test
Weight of 1-hour pad test
Severity of Incontinence.
It is evaluated by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short FormInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The ICIQ score with a range from 0-21; the higher the score the worse of incontinence
Sexual Function
It is evaluated by International Index of Erectile Function Score (IIEF-5). The IIEF-5 score is the sum of the ordinal response to the 5 items. The lowest the score, the more severe of erectile dysfunction
Severity of Incontinence
The number of pads used
Complications
It is evaluated by CTCAE Grade 5
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