Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Change in EPIC questionnaire score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Intervention: Non-invasive pelvic floor neuromuscular stimulation (Device)
Outcomes
Primary Outcomes
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.
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.
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
- Treatment failure(From enrollment to 3 months after initiation of treatment)
Investigators
Jesse N. Mills, MD
Clinical Professor of Urology
University of California, Los Angeles