Using nerve stimulation to treat bladder issues in Veterans
Official title: Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data
Run by VA Office of Research and Development · NCT05141487 · Data updated 2026-11-12
This study is testing a new nerve stimulation method to help Veterans with bladder issues feel better and manage their urinary incontinence without using catheters.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | October 3, 2022 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT05141487 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include Veterans over 18 with neurogenic lower urinary tract dysfunction and a functional bladder capacity greater than 100 mL.
✕Probably not a fit
Patients with active urinary tract infections, severe neurological diseases, or those requiring certain medical interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to assess the feasibility of a new nerve stimulation technique called triggered sacral neuromodulation for treating neurogenic detrusor overactivity (NDO) in Veterans. A wireless bladder sensor will be implanted to monitor bladder activity and provide feedback for stimulation, allowing for treatment during specific phases of bladder filling. The study will evaluate how this method can increase bladder capacity and reduce pressure without the need for catheters, ultimately improving the quality of life for Veterans suffering from urinary incontinence. The research focuses on a population disproportionately affected by NDO due to spinal cord injuries and other neurological conditions.
Why it matters
Potential benefit: If successful, this approach could significantly improve bladder control and quality of life for Veterans with neurogenic bladder issues.
How similar studies have gone: While similar techniques have shown promise in animal studies, this specific approach has not yet been tested in humans.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of neurogenic lower urinary tract dysfunction consistent with International Continence Society definition which includes all bladder/urinary sphincter dysfunction related to any neurological disease or injury * Male or female * If SCI, time from injury \> 6 months to allow for recovery from the acute phase * Can tolerate lying prone \> 1 hour * Functional bladder capacity \> 100 mL confirmed by urodynamics examination * Low risk of upper urinary tract deterioration * Over 18 years of age, able to speak and understand English, capacity for consent Exclusion Criteria: * Active urinary tract infection * Chronic indwelling or suprapubic catheter usage * Severe or rapidly progressive neurologic disease * Abnormal sacral anatomy * Anticipated need for MRI of body parts below the head * Pelvic organ prolapse beyond the hymen * Pregnancy * Treatment with Botox injection within last six months * Current treatment with percutaneous tibial nerve stimulation or other forms of neuromodulation * History of sacral neuromodulation treatment or presence of sacral neuromodulation leads or implant * Interstitial cystitis/bladder pain syndrome * Benign prostatic hyperplasia preventing catheterization to empty * History of anatomically relevant pelvic or anti-incontinence surgery
Where it's running
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Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Steve J Majerus, PhD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Steve J Majerus, PhD
- Email: Steve.Majerus@va.gov
- Phone: (216) 791-3800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.