Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: VA Office of Research and Development
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT05141487 · last updated 2026-01-15