Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Jesse N. Mills, MD (ucla)

Description

Summary

Urinary incontinence is a common complication following prostatectomy and affects a substantial proportion of patients. Despite advances in surgical technique, many patients experience persistent symptoms that negatively impact quality of life. Current management strategies include pelvic floor muscle training, biofeedback and physical therapy, and surgical options. However, these approaches may be limited by adherence, access, and invasiveness, leaving a subset of patients with ongoing symptoms despite standard care.

Non-invasive pelvic floor neuromuscular stimulation has emerged as a potential adjunct for pelvic floor rehabilitation by inducing supramaximal muscle contractions and enhancing neuromuscular activation without requiring active patient effort. Preliminary studies suggest that high-intensity electromagnetic stimulation may improve patient-reported continence outcomes and pad usage in women as well as men following radical prostatectomy, though existing data are limited by small sample sizes and short follow-up durations. Additionally, no clinical studies exist evaluating outcomes in men following prostatectomy prior to established stress incontinence.

Given these limitations, further evaluation is needed to assess the feasibility, tolerability, and short-term effectiveness of this intervention in a post-prostatectomy population.

Details

This prospective study aims to evaluate feasibility, safety, and patient-reported continence outcomes associated with non-invasive pelvic floor neuromuscular stimulation in men with urinary incontinence following prostatectomy. Findings may inform future clinical implementation and guide the design of larger, controlled trials.

Keywords

Urinary Incontinence, Prostatectomy, Neuromuscular stimulation, HIFEM, Non-invasive pelvic floor neuromuscular stimulation

Eligibility

You can join if…

Open to males ages 18 years and up

You CAN'T join if...

  • Cardiac pacemaker, implanted defibrillator, or other contraindicated metallic or electronic implants
  • Active urinary tract infection
  • Hematuria of unknown origin
  • Untreated bladder outlet obstruction
  • Neurologic conditions affecting bladder function (e.g., multiple sclerosis, Parkinson disease, spinal cord injury)
  • Active fever or systemic inflammatory condition at the time of treatment
  • Any condition deemed by the investigator to make participation unsafe

Location

  • UCLA The Men's Clinic
    Santa Monica California 90403 United States

Lead Scientist at University of California Health

  • Jesse N. Mills, MD (ucla)
    HS Clinical Professor, Urology, Medicine. Authored (or co-authored) 66 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
Device used for non-invasive pelvic floor neuromuscular stimulation
ID
NCT07534696
Study Type
Interventional
Participants
Expecting 37 study participants
Last Updated