Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder (NCT05141487)
Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data
๐ฉบ Plain-English Summary (8th-Grade Level)
Incontinence associates with military service and post-traumatic stress disorder in both male and female Veterans. Neurogenic detrusor overactivity (NDO) is caused by spinal cord injury or disorder, or peripheral neurodegenerative conditions, and causes urine leakage at low volumes. NDO is disproportionately experienced by Veterans and treatment effectiveness varies greatly between individuals. This project will demonstrate the feasibility of a new type of nerve stimulation-triggered sacral neuromodulation-to treat NDO in Veterans. A wireless bladder sensor will be inserted into the bladder to transmit a feedback signal enabling stimulation from a percutaneous lead. The wireless sensor will also measure NDO symptoms during simulated activities of daily living without catheters. Catheter-free detection of bladder activity will improve the outcomes of neuromodulation evaluations for Veterans with NDO. Future work could use the triggered neuromodulation system to study other methods of nerve stimulation to treat bladder, bowel, or sexual dysfunction.
Who can join: Review the eligibility criteria below.
Location: Louis Stokes VA Medical Center, Cleveland, OH โ Cleveland, Ohio
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Louis Stokes VA Medical Center, Cleveland, OH โ Cleveland, Ohio
๐ Contact the Study Coordinator
Phone: (216) 791-3800
Email: Steve.Majerus@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence โ La Jolla, California
- Clinical Study of External Electrical Stimulation for Male Incontinence โ Monroe, Connecticut
- Use of Sildenafil for Treatment of Urinary Incontinence โ Galveston, Texas
- WI-INTUIT: Bridging Community Based Continence Promotion and Primary Care โ San Diego, California
Explore by condition: All Urinary Incontinence clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.