NCT05141487 Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
| NCT ID | NCT05141487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Urinary Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2022-10-03 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2022-10-03 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Steve J Majerus, PhD
PRINCIPAL INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH
Frequently Asked Questions
Who can join the NCT05141487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05141487 currently recruiting?
Yes, NCT05141487 is actively recruiting participants. Contact the research team at Steve.Majerus@va.gov for enrollment information.
Where is the NCT05141487 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05141487 clinical trial?
NCT05141487 is sponsored by VA Office of Research and Development. The principal investigator is Steve J Majerus, PhD at Louis Stokes VA Medical Center, Cleveland, OH. The trial plans to enroll 16 participants.