Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
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
Chinese University of Hong Kong
184 participants
Jul 29, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Undergone robotic radical prostatectomy
- Able to carry out 1-hour pad test
- Voluntary participation and signing of the informed consent form
Exclusion Criteria9
- Pre-existing stress urinary incontinence
- Post-void residual urine greater than 200ml
- Active urinary tract infection
- Urethral or bladder fistula
- History of pelvic irradiation
- Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)
- Previous surgery for SUI
- Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence
- Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant
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Interventions
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
Locations(1)
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NCT06589869