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Electrical Stimulation for Continence After Spinal Cord Injury
NCT02978638 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Finetech Vocare Bladder System
Study Locations (4)
California
- Palo Alto Veterans Institute for Research — Palo Alto
- Santa Clara Valley Medical Center — San Jose
New Mexico
- University of New Mexico — Albuquerque
Ohio
- MetroHealth Medical Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-09 |
| Est. Completion | 2025-09-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02978638
The ClinicalTrials.gov registry entry for NCT02978638 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Palo Alto Veterans Institute for Research, which has 50 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 1 intervention — of which Finetech Vocare Bladder System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02978638 reports 4 study locations spanning 3 distinct geographic areas — top geographies include California, New Mexico, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02978638 about?
NCT02978638 is a clinical study titled "Electrical Stimulation for Continence After Spinal Cord Injury". 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 commercial...
What is the current status of trial NCT02978638?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2014-09. Estimated completion is 2025-09-28.
What conditions does trial NCT02978638 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Neurogenic Bladder, Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02978638?
The interventions under investigation include: Finetech Vocare Bladder System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02978638?
This trial is sponsored by Palo Alto Veterans Institute for Research, which has 50 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02978638 being conducted?
This trial has 4 study locations across California, New Mexico, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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