NCT06803602

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Holmium Laser Prostate Surgery
• Radical Prostatectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2025-01-31
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study