Status:
RECRUITING
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Urinary Incontinence , Stress
Prostatectomy
Eligibility:
MALE
18+ years
Phase:
NA
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 s...
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 f...
Eligibility Criteria
Inclusion
- Undergone robotic radical prostatectomy
- Able to carry out 1-hour pad test
- Voluntary participation and signing of the informed consent form
Exclusion
- 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
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06589869
Start Date
July 29 2022
End Date
June 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong