Actively Recruiting
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
Led by VA Office of Research and Development · Updated on 2026-01-15
16
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neurogenic lower urinary tract dysfunction related to neurological disease or injury as defined by the International Continence Society
- Male or female
- If spinal cord injury is present, injury occurred more than 6 months ago
- Able to tolerate lying face down for more than 1 hour
- Functional bladder capacity greater than 100 mL confirmed by urodynamics
- Low risk for upper urinary tract damage
- Age 18 years or older, able to speak and understand English, and capable of giving consent
You will not qualify if you...
- Active urinary tract infection
- Use of chronic indwelling or suprapubic catheter
- Severe or rapidly progressing neurological disease
- Abnormal sacral anatomy
- Expected need for MRI scans below the head
- Pelvic organ prolapse beyond the hymen
- Pregnancy
- Botox treatment within the last 6 months
- Current use of percutaneous tibial nerve stimulation or other neuromodulation treatments
- Previous sacral neuromodulation treatment or presence of related implants
- Interstitial cystitis or bladder pain syndrome
- Benign prostatic hyperplasia preventing catheterization
- History of relevant pelvic or anti-incontinence surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
Research Team
S
Steve J Majerus, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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