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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06803602
Status
Enrolling By Invitation

Conditions

  • Holmium Laser Prostate Surgery
  • Radical Prostatectomy

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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).

Key Dates

Start date
Jul 1, 2025
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
2,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    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.
  • Sham Comparator: Placebo Group
    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.

Primary Outcome Measure

Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) [ Time Frame: Baseline, 6 weeks, 15 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-

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