Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data
VA Office of Research and Development
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.
Description
Neurogenic detrusor overactivity (NDO) resulting from spinal cord injury or disorder (SCI/D) affects 80% of individuals with SCI/D. It is also associated with peripheral neurodegenerative conditions such as Parkinson's disease, multiple sclerosis, diabetic neuropathy, or stroke. NDO causes urinary incontinence that profoundly impacts dignified, independent living, associates with numerous comorbidities and fall risk, and is a leading factor in functional decline among the elderly. Urinary incontinence contributes to social isolation and clinical depression and associates with military service…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Cri…
Interventions
- DeviceUroMonitor
The UroMonitor is small wireless sensor that is temporarily inserted into the bladder. While in the bladder it transmits bladder pressure measurements to an external radio. After a short period of use it is removed using an extraction string and discarded.
- DeviceASCU
The ASCU is a wearable nerve stimulator containing a radio and computer processor. It receives pressure information from the bladder and determines when to turn on sacral nerve stimulation. It is only used temporarily during research visits.
Location
- Louis Stokes VA Medical Center, Cleveland, OHCleveland, Ohio