Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder (NCT05141487) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
United States16 participantsStarted 2022-10-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time between voids during conditional SNM
Timeframe: Through study completion, an average of 2 weeks
2
Detrusor contraction period during conditional SNM
Timeframe: Through study completion, an average of 2 weeks
3
Voided urine volume during conditional SNM
Timeframe: Through study completion, an average of 2 weeks