Prostatectomy, Urinary Incontinence
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Change in EPIC questionnaire score | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | From enrollment to 3 months after initiation of treatment | Treatment failure is defined as requiring procedural or surgical intervention for urinary incontinence following prostatectomy. |
Countries
United States