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

NCT07534696 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB #26-0324
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Prostatectomy

Keywords

Neuromuscular stimulation; HIFEM

Outcome Measures

Primary Outcomes (3)

• Change in EPIC questionnaire score

  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

  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

  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 Outcomes (1)

• Treatment failure

  From enrollment to 3 months after initiation of treatment

Study Arms (1)

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.

Device: Non-invasive pelvic floor neuromuscular stimulation

Interventions

Non-invasive pelvic floor neuromuscular stimulation DEVICE

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.

Non-invasive pelvic floor neuromuscular stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA The Men's Clinic

Santa Monica, California, 90403, United States

Location

Related Publications (2)

• Tosun H, Akinsal EC, Bas U, Sonmez G, Baydilli N, Demirci D. Evaluating the Efficacy of High-Intensity Focused Electromagnetic (HIFEM) Therapy for Postprostatectomy Incontinence in Men. Ther Clin Risk Manag. 2025 Aug 30;21:1309-1315. doi: 10.2147/TCRM.S534674. eCollection 2025.

  PMID: 40909763 BACKGROUND

• Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002/lsm.23106. Epub 2019 Jun 7.

  PMID: 31172580 BACKGROUND

Related Links

• Device used for non-invasive pelvic floor neuromuscular stimulation

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jesse N Mills, MD

CONTACT

3107943058; JNMills@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Urology

Model Details: This study is a prospective, single-arm feasibility study evaluating non-invasive pelvic floor neuromuscular stimulation for post-prostatectomy urinary incontinence using the Zimmer PF Toner medical device.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 16, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)