Using HIFEM technology to treat urinary incontinence in men after prostate surgery
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
This study is testing if a new HIFEM treatment can help men who have had prostate surgery with their urinary incontinence better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Months and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06589869 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in treating stress urinary incontinence in Chinese men who have undergone robotic radical prostatectomy. Participants will be randomly assigned to receive either HIFEM-assisted pelvic floor muscle training or standard care. The study aims to determine if the HIFEM technology provides better outcomes compared to traditional methods. The trial will include a one-hour pad test to assess urinary incontinence levels.
Who should consider this trial
Good fit: Ideal candidates are Chinese men who have undergone robotic radical prostatectomy and are experiencing stress urinary incontinence.
Not a fit: Patients with pre-existing stress urinary incontinence or those with conditions contraindicated for electromagnetic therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve urinary control and quality of life for men suffering from incontinence after prostate surgery.
How similar studies have performed: While the use of HIFEM technology is gaining interest, this specific application in post-prostatectomy urinary incontinence is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chi Fai NG, MD — Chinese University of Hong Kong
- Study coordinator: Chi Fai NG, MD
- Email: ngcf@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.