Home › Urinary Incontinence › NCT05141487
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the 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.
What is being tested
- UroMonitor (device)
- ASCU (device)
Sponsor: VA Office of Research and Development · Participants: 16 · Started: Oct 3, 2022
Contact the study team
- Steve J Majerus, PhD · Phone: (216) 791-3800
Official record on ClinicalTrials.gov — NCT05141487
Locations in the U.S.
| Ohio | Louis Stokes VA Medical Center, Cleveland, OH, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.