CClinicalTrials.gg
Enrolling by invitationNCT07534696Updated Oct 5, 2026

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

An interventional study of Non-invasive pelvic floor neuromuscular stimulation in Urinary Incontinence and Prostatectomy, sponsored by University of California, Los Angeles. Enrolling by invitation at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Updated Oct 5, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence
  • Prostatectomy

Keywords

  • Neuromuscular stimulation
  • HIFEM
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 37 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceNon-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.

06

What researchers measure

Primary outcomes

  1. Change in EPIC questionnaire score

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

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

  2. 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.

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

  3. Continence

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

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

Secondary outcomes

  1. Treatment failure

    Treatment failure is defined as requiring procedural or surgical intervention for urinary incontinence following prostatectomy.

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

07

Study locations

1 site
  • UCLA The Men's Clinic
    Santa Monica, California 90403, United States
08

References and documents

Publications

  • 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. PubMed 40909763 ↗
  • 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. PubMed 31172580 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 31, 2026→Dec 31, 2026
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion Aug 31, 2026→Dec 31, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07534696
Lead sponsor
University of California, Los Angeles
Responsible party
Jesse N. Mills, MD (Clinical Professor of Urology, University of California, Los Angeles) — Principal investigator
First posted
Apr 16, 2026
Start date
May 20, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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