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.
This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise. Randomization will be performed for patients when the subject has completed the informed consent for study participation. Randomization will be performed in 1:1 ratio into 2 arms: HIFEM assisted (BTL EMsella) pelvic floor muscle training (Arm A) plus Standard of care or Standard of care (Arm B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
184
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.
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
Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGWeight of 1-hour pad test
Weight of 1-hour pad test
Time frame: Baseline, Month 1, Month 3 and Month 6
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
Time frame: Baseline, Month 1, Month 3 and Month 6
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
Time frame: Baseline, Month 1, Month 3 and Month 6
Severity of Incontinence
The number of pads used
Time frame: Baseline, Month 1, Month 3 and Month 6
Complications
It is evaluated by CTCAE Grade 5
Time frame: Month 1, Month 3 and Month 6
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