Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT05141487
Status
Recruiting
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Conditions

  • Urinary Bladder, Neurogenic
  • Urinary Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UroMonitor — DEVICE
    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.
  • ASCU — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 3, 2022
Status verified
Jan 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
16 participants (estimated)

Arms

  • Arm: Conditional SNM
    This group receives conditional sacral neuromodulation, applied intermittently based on sensor data describing bladder activity.
  • Arm: Continuous SNM
    This group receives continuous SNM, applied constantly throughout the bladder filling cycle.

Primary Outcome Measure

Time between voids during conditional SNM [ Time Frame: Through study completion, an average of 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Steve J Majerus, PhD
[email protected]
216-791-3800
Steve J Majerus, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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