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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07534696
Enrollment
37
Registered
2026-04-16
Start date
2026-05-20
Completion date
2026-12-31
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatectomy, Urinary Incontinence

Keywords

Neuromuscular stimulation, HIFEM

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.

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.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in EPIC questionnaire scoreFrom enrollment to 3 months after initiation of treatmentThe Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire assessing urinary, bowel, sexual, and hormonal outcomes.
Change in ICIQ-UI questionnaire scoreFrom enrollment to 3 months after initiation of treatmentThe International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) short form is a validated questionnaire assessing urinary incontinence.
ContinenceFrom enrollment to 3 months after initiation of treatmentContinence is measured by number of pads used per 24 hours, with continence defined as less than one pad used per day.

Secondary

MeasureTime frameDescription
Treatment failureFrom enrollment to 3 months after initiation of treatmentTreatment failure is defined as requiring procedural or surgical intervention for urinary incontinence following prostatectomy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026