Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Active urinary tract infection

Chronic indwelling or suprapubic catheter usage

Severe or rapidly progressive neurologic disease

Abnormal sacral anatomy

Trial design

Treatments tested in this trial

  • UroMonitor
  • ASCU

Treatment groups

16 Participants
are divided into 2 treatment groups