Comparing electrical nerve stimulation and muscle training for urinary incontinence after prostate surgery
Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence: A Propensity Score Matching Analysis
This study is testing whether electrical nerve stimulation or muscle training helps men who have urinary incontinence after prostate surgery feel better and regain control.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Shanghai Institute of Acupuncture, Moxibustion and Meridian Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06130306 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of electrical pudendal nerve stimulation (EPNS) versus pelvic floor muscle training (PFMT) combined with transanal electrical stimulation (TES) in patients experiencing urinary incontinence following radical prostatectomy. By employing a propensity score matching approach, the study seeks to ensure balanced comparisons between the two treatment modalities while controlling for confounding factors. The focus is on patients who have developed incontinence at least one month post-surgery, with documented episodes of incontinence. The outcomes will provide insights into which treatment may offer better continence restoration for this patient population.
Who should consider this trial
Good fit: Ideal candidates are men who have experienced urinary incontinence at least one month after undergoing radical prostatectomy and have documented incontinence episodes.
Not a fit: Patients with high pathological risk factors, preoperative incontinence, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the more effective treatment option for urinary incontinence, improving patient quality of life after prostate surgery.
How similar studies have performed: Previous studies have shown promising results comparing various treatments for post-radical prostatectomy incontinence, but this specific approach using propensity score matching is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Onset of urinary incontinence at least 1 month post-RP * Minimum two documented incontinence episodes per week in a 7-day bladder diary * Pathological confirmation of no residual cancer post-RP Exclusion Criteria: * High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors) * Preoperative incontinence * Prior anticholinergic treatment * Urinary tract infection or hematuria * Postvoid residual volume exceeding 100 ml (determined by bladder ultrasound) * Neurological disorders * Urethral stricture
Where this trial is running
Shanghai
- Shanghai research institute of acupuncture and meridian — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Siyou Wang — Shanghai research institute of acupuncture and meridian
- Study coordinator: Siyou Wang, M.M
- Email: wangsiyou1234@163.com
- Phone: +86-13916145894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.