MedTrace Logo

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

NCT06803602 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2025-12-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Mitchell R Humphreys, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-03-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803602 on ClinicalTrials.gov