HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery

Launched by MAYO CLINIC · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called High-Intensity Focused Electromagnetic (HIFEM) technology to help men recover better after prostate surgery, specifically after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP). The goal is to see if this technology can improve urinary control and overall quality of life for patients who are experiencing urinary incontinence one month after their surgery.

To participate in the trial, you must be a male who has had either RP or HoLEP and is currently dealing with urinary incontinence. You should also be able to make your own medical decisions and complete some questionnaires during the study. If you’re interested, participants can expect to receive the HIFEM treatment and will be monitored closely throughout the trial. It's important to know that there are certain conditions that would exclude someone from joining, such as having certain neurological issues or other medical conditions affecting the bladder. If you think you might qualify and want to learn more, this could be an opportunity to explore a new way to improve your recovery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects who are male
• • Post-radical prostatectomy or post HoLEP
• • Experiencing urinary incontinence one-month post-RP
• • Have the capacity to make their own medical decisions
• • Able to complete the questionnaires and visits required.
• Exclusion Criteria:
• • Subjects who are not male
• • Not post-radical prostatectomy or post HoLEP
• • Neurologic disease
• • Atonic or hypofunctional bladder (bladder contractility index (BCI) \< 100; BCI = pDetQmax+5Qmax)
• • Status post pelvic radiation
• • Past surgical history of other GU surgeries
• • Gross hematuria
• • Concomitant use of medications that cause muscle relaxation or inhibition
• • Indwelling foley catheter at time of treatment
• • Documented urine leak
• • Not experiencing urinary incontinence
• • Do not have the capacity to make their own medical decisions
• • Unable to complete the questionnaires provided.