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ENROLLING BY INVITATION
NCT06803602
NA

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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).

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

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

2100

Start Date

2025-07-01

Completion Date

2028-03

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States