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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Weight of 1-hour pad test
Study Overview
Brief 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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to — (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Undergone robotic radical prostatectomy
- •Able to carry out 1-hour pad test
- •Voluntary participation and signing of the informed consent form
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Weight of 1-hour pad test
Time Frame: Baseline, Month 1, Month 3 and Month 6
Weight of 1-hour pad test
Secondary Outcomes
- Severity of Incontinence.(Baseline, Month 1, Month 3 and Month 6)
- Sexual Function(Baseline, Month 1, Month 3 and Month 6)
- Severity of Incontinence(Baseline, Month 1, Month 3 and Month 6)
- Complications(Month 1, Month 3 and Month 6)
Investigators
Chi Fai NG
Professor
Chinese University of Hong Kong