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Not Yet RecruitingNCT07534696

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
37 (estimated)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENon-invasive pelvic floor neuromuscular stimulationParticipants 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.

Timeline

Start date
2026-04-10
Primary completion
2026-08-31
Completion
2026-12-31
First posted
2026-04-16
Last updated
2026-04-16

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07534696. Inclusion in this directory is not an endorsement.