What this study is
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).
What's being tested
- EMSELLA®
Intervention · DEVICE
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
Intervention · 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.
Study details
- Official title
- Evaluating the Efficacy of High-Intensity Focused Electromagnetic Technology in Improving the Time of Recovery of Urinary Control of Continence and Quality of Life for Post-Surgical Patients
- Sponsor
- Mayo Clinic
- Conditions
- Holmium Laser Prostate Surgery · Radical Prostatectomy
- Enrolling
- 2,100 people
- Starts
- 2025-07-01
- Est. completion
- 2028-03
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMayo Clinic in Arizona
Scottsdale, Arizona, United States
Study team
Sponsor
Mayo Clinic
Study ID 24-010450
Principal investigator
Mitchell R Humphreys, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.