Recovery of Bladder and Sexual Function After Human Spinal Cord Injury (NCT04193709) | Clinical Trial Compass
CompletedNot Applicable
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
United States61 participantsStarted 2021-01-04
Plain-language summary
This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.
Who can participate
Age range
18 Years – 70 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.
Arm 1 Inclusion Criteria:
* At least 18 years of age;
* AIS A to D;
* Neurogenic bladder and bowel dysfunction;
* Stable medical condition
Arm 2 Inclusion Criteria:
* At least 18 years of age;
* AIS A to D;
* Neurogenic bladder and bowel dysfunction;
* Use of intermittent catheterization for bladder emptying;
* Prior implantation of a Medtronic scES array
Arms 1 and 2 Exclusion Criteria:
* Prior Botox injections of the bladder and/or bladder augmentation surgery;
* Colostomy bag,
* Ventilator dependent;
* Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
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
19.1194 Will determine change in systolic blood pressure during filling during cystometry
Timeframe: 2 hours
2
19.1194 Will determine maximum change in systolic blood pressure during Anorectal Manometry assessments
Timeframe: 1 hour
3
17.1024 BB-IS-2 Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)