Electrical Stimulation for Continence After Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT02978638|
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : March 10, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Neurogenic Bladder Incontinence||Device: Finetech Vocare Bladder System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Finetech Vocare Bladder System
This is a pilot study of the Finetech Vocare Bladder System to improve continence and voiding in human subjects with chronic spinal cord injury. Each subject will act as their own control, comparing function with the Finetech Vocare Bladder System in use and not in use.
Device: Finetech Vocare Bladder System
Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.
- Bladder capacity [ Time Frame: Change from baseline bladder capacity at 12-month follow-up visit ]Bladder capacity (ml.) measured during filling cystometry
- Frequency of incontinence of urine [ Time Frame: Change from baseline frequency of incontinence of urine at 12-month follow-up visit ]Frequency of incontinence determined from diary data collected by the subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978638
|Contact: Graham H. Creasey, MD||650-493-5000 ext 65040|
|Contact: Zoia Latev, PhD||650-493-5000 ext 63048|
|United States, California|
|Palo Alto Veterans Institute for Research||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Graham Creasey, MD 650-493-5000 ext 65040|
|Contact: Zoia Latev, PhD 650-493-5000 ext 63048|
|Santa Clara Valley Medical Center||Recruiting|
|San Jose, California, United States, 95128|
|Contact: Harminder Singh, MD 408-885-4646 email@example.com|
|Contact: Michael Prutton 4088853961 firstname.lastname@example.org|
|Principal Investigator: Harminder Singh, MD|
|Sub-Investigator: Christopher Elliott, MD PhD|
|United States, Ohio|
|MetroHealth Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Dennis Bourbeau, PhD email@example.com|
|Contact: Kimberly Schach firstname.lastname@example.org|
|Principal Investigator:||Graham H. Creasey, MD||Palo Alto Veterans Institute for Research|
|Study Director:||Reza Ehsanian, MD PhD||University of New Mexico|