Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy

Recruiting now · Not applicable

Conditions studied: Urinary Incontinence , Stress, Prostatectomy

In brief

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.

Key facts

Study ID

NCT06589869

Run by

Chinese University of Hong Kong

People needed

184

Starts

2022-07-29

Expected to finish

2026-06-01

Last updated by the study team

2024-09-19

Who can join

Age: 2 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Undergone robotic radical prostatectomy
• Able to carry out 1-hour pad test
• Voluntary participation and signing of the informed consent form

You may not qualify if…

• 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

Where it is running

• Prince of Wales Hospital — Shatin, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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