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

Mayo Clinic

Status: Invitation-only

Conditions: Holmium Laser Prostate Surgery; Radical Prostatectomy

Treatments: Device: EMSELLA®; Device: Sham Comparator Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06803602

24-010450

Details and patient eligibility

About

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).

Enrollment: 2,100 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,100 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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.

Treatment:

Device: EMSELLA®

Placebo Group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Comparator Device