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NCT06589869
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Conditions: Urinary Incontinence , Stress, Prostatectomy
Sex: Male
Ages: 18 Months – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 184
Sponsor: Chinese University of Hong Kong
Location: Prince of Wales Hospital Shatin
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 Criteria
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
Source: ClinicalTrials.gov (NCT06589869). StuddyBuddy aggregates publicly available trial information.