Electrical Stimulation for Continence After Spinal Cord Injury (NCT02978638) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Electrical Stimulation for Continence After Spinal Cord Injury
United States10 participantsStarted 2014-09
Plain-language summary
This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation.
The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation.
Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.
Who can participate
Age range
22 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:
Subjects will be included if they meet all of the following criteria:
* Complete spinal cord injury (AIS grade A) of at least 2 years duration with neurological level (ISNCSCI level) below C4
* Impaired bladder emptying due to Detrusor External Sphincter Dyssynergia-DESD (unco-ordinated contraction of bladder and external urethral sphincter) as shown on video-urodynamic testing.
* Impaired continence due to detrusor hyper-reflexia
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
* Absence of reflex contractions of the bladder as shown on urodynamic testing
* Absence of reflex contractions of the external urethral sphincter as shown on urodynamic testing with EMG
* External sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery
* History of pelvic fracture
* Subjects on anticoagulants or with coagulation disorders
* Immunosuppressed subjects
* Active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric areas
* Active untreated infection
* Active implanted medical device such as cardiac pacemaker or defibrillator
* Progressive spinal cord injury
* Pregnancy
* Mechanical ventilator dependency
* Any other significant co-morbidity or illness that would preclude their participation or increase the risk to them of participating in the study
* Inability or unwillingness to follow study protocol or give informed consent
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
Bladder capacity
Timeframe: Change from baseline bladder capacity at 12-month follow-up visit