Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Contact Information
Primary
Steve J Majerus, PhD
Steve.Majerus@va.gov
(216) 791-3800
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2025-10-29
Participants
Target number of participants: 16
Treatments
Conditional SNM
This group receives conditional sacral neuromodulation, applied intermittently based on sensor data describing bladder activity.
Continuous SNM
This group receives continuous SNM, applied constantly throughout the bladder filling cycle.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov