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OpenTrials
Enrolling by Invitation

NCT Number: NCT07534696

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA The Men's Clinic

Santa Monica, California, 90403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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