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Clinical Trials/NCT07534696
NCT07534696
Not yet recruiting
Not Applicable

Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy

University of California, Los Angeles1 site in 1 country37 target enrollmentStarted: April 10, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
37
Locations
1
Primary Endpoint
Change in EPIC questionnaire score

Overview

Brief 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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men aged 18 years or older
  • Undergoing or underwent prostatectomy at UCLA
  • Able to provide informed consent

Exclusion Criteria

  • 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

Arms & Interventions

Non-invasive pelvic floor neuromuscular stimulation

Experimental

Participants will complete an 8-week intervention (12 sessions total) of non-invasive pelvic floor neuromuscular stimulation, with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention.

Intervention: Non-invasive pelvic floor neuromuscular stimulation (Device)

Outcomes

Primary Outcomes

Change in EPIC questionnaire score

Time Frame: From enrollment to 3 months after initiation of treatment

The Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire assessing urinary, bowel, sexual, and hormonal outcomes.

Change in ICIQ-UI questionnaire score

Time Frame: From enrollment to 3 months after initiation of treatment

The International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) short form is a validated questionnaire assessing urinary incontinence.

Continence

Time Frame: From enrollment to 3 months after initiation of treatment

Continence is measured by number of pads used per 24 hours, with continence defined as less than one pad used per day.

Secondary Outcomes

  • Treatment failure(From enrollment to 3 months after initiation of treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jesse N. Mills, MD

Clinical Professor of Urology

University of California, Los Angeles

Study Sites (1)

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