HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery
NCT ID: NCT06803602
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
2100 participants
INTERVENTIONAL
2025-07-01
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment Group
Subjects randomized to the treatment group will receive 2, 30-minute sessions, weekly for 3 weeks using the Emsella device.
After a 1 week wash-out period, subjects still experiencing urinary leakage will have the option to continue treatment for 3 additional weeks.
EMSELLA®
Subjects will receive 100% intensity of the EMSELLA® (BTL Industries, Marlborough, MA) High-Intensity Focused Electromagnetic (HIFEM) treatment, in a single 30-minute session, twice per week for 3 weeks.
Placebo Group
Subjects randomized to the placebo group will receive 2, 30-minute sessions, weekly for 3 weeks using a sham comparator device.
After a 1 week wash-out period, subjects in the placebo group who are experiencing urinary leakage will be offered the opportunity to cross-over to an active treatment group for an additional 3 weeks.
Sham Comparator Device
Subjects will be asked to sit on the EMSELLA® (BTL Industries, Marlborough, MA) treatment head which will be powered off and instead have a small remote control vibration device that will simulate active treatment, in a single 30-minute session, twice per week for 3 weeks.
Interventions
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EMSELLA®
Subjects will receive 100% intensity of the EMSELLA® (BTL Industries, Marlborough, MA) High-Intensity Focused Electromagnetic (HIFEM) treatment, in a single 30-minute session, twice per week for 3 weeks.
Sham Comparator Device
Subjects will be asked to sit on the EMSELLA® (BTL Industries, Marlborough, MA) treatment head which will be powered off and instead have a small remote control vibration device that will simulate active treatment, in a single 30-minute session, twice per week for 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mitchell Humphreys
Principal Investigator
Principal Investigators
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Mitchell R Humphreys, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-010450
Identifier Type: -
Identifier Source: org_study_id