TerminatedNot Applicable

Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury

Stopped: The study was unable to meet enrollment goals

United States5 participantsStarted 2019-08-07

Plain-language summary

The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.

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: * Age \> 18 years * Ability to implant device less than 12 weeks post-spinal cord injury (SCI) * Presence of acute SCI at or above T12 * American Spinal Injury Association (ASIA) Scale A or B * Expectation to perform clean intermittent catheterization (CIC) personally or have caretaker perform CIC Exclusion Criteria: * Inability to perform CIC * Pre-existing SCI * Pre-existing progressive neurological disorder * Autonomic dysreflexia * Prior sacral back surgery * Posterior pelvic fracture with distortion of the sacroiliac joint * Prior urethral sphincter or bladder dysfunction * Chronic urinary tract infections prior to SCI * Pregnancy at the time of enrollment * Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure * Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure * Active untreated infection * Traumatic injury to the genitourinary system * Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology

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

Maximum Cystometric Capacity

Timeframe: 12 months

Quality of Life Differences Measured by Mean SCI-QoL

Timeframe: 12 months

Number of Urinary Tract Infections Requiring Antibiotics

Timeframe: from enrollment through the end of follow-up at 12 months

Trial details

NCT IDNCT03083366

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20

Results submitted2024-05-16

View on ClinicalTrials.gov More Spinal Cord Injury, Acute trials