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

May 21, 2026 updated by: Jesse N. Mills, MD, University of California, Los Angeles

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive pelvic floor neuromuscular stimulation
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.
Device: Non-invasive pelvic floor neuromuscular stimulation
Participants will complete an 8-week intervention (12 sessions total), with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 3 months after initiation of treatment
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.
From enrollment to 3 months after initiation of treatment
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.
From enrollment to 3 months after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure
Time Frame: From enrollment to 3 months after initiation of treatment
Treatment failure is defined as requiring procedural or surgical intervention for urinary incontinence following prostatectomy.
From enrollment to 3 months after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #26-0324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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