By InvitationNot Applicable

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

United States2,100 participantsStarted 2025-07-01

Plain-language summary

The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).

Who can participate

Age range

18 Years – 100 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)

Timeframe: Baseline, 6 weeks, 15 weeks

Pad weight test

Timeframe: Baseline, 6 weeks, 15 weeks

Trial details

NCT IDNCT06803602

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Holmium Laser Prostate Surgery trials