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

NCT06803602 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-010450
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)

  The International Consultation on Incontinence Questionnaire (ICIQ-SF) is a 4-item questionnaire that assesses the frequency, amount, and impact of urinary leakage. The ICIQ-SF has a scoring range of 0-21, with higher scores indicating more severe symptoms.

  Baseline, 6 weeks, 15 weeks

• Pad weight test

  For the pad weight test, subjects will be provided with a small scale and asked to measure the weight of their pad before and after wearing for 24 hours.

  Baseline, 6 weeks, 15 weeks

Secondary Outcomes (3)

• Change in International Prostate Symptom Score (IPSS)

  Baseline, 6 weeks, 15 weeks

• Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)

  Baseline, 6 weeks, 15 weeks

• Change in Quality of Life Scale

  Baseline, 6 weeks, 15 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Device: EMSELLA®

Placebo Group

SHAM COMPARATOR

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.

Device: Sham Comparator Device

Interventions

Sham Comparator Device 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.

Placebo Group

EMSELLA® 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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Mitchell R Humphreys, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)