Electrical Stimulation for Continence After Spinal Cord Injury

NCT02978638 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: CRE0004AGGW81XWH-14-2-0132
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief 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

Spinal Cord Injury; Neurogenic Bladder; Incontinence

Keywords

Spinal cord injury; Bladder capacity; Electrical stimulation; Continence; Urodynamics

Outcome Measures

Primary Outcomes (1)

• Bladder capacity

  Bladder capacity (ml.) measured during filling cystometry

  Change from baseline bladder capacity at 12-month follow-up visit

Secondary Outcomes (1)

• Frequency of incontinence of urine

  Change from baseline frequency of incontinence of urine at 12-month follow-up visit

Study Arms (1)

Finetech Vocare Bladder System

OTHER

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

Interventions

Finetech Vocare Bladder System DEVICE

Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.

Finetech Vocare Bladder System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• VA Palo Alto Health Care System: collaborator
• Stanford University: collaborator
• Case Western Reserve University: collaborator
• Santa Clara Valley Medical Center: collaborator
• University of New Mexico: collaborator

Study Sites (4)

Palo Alto Veterans Institute for Research

Palo Alto, California, 94304, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (13)

• Creasey GH, Grill JH, Korsten M, U HS, Betz R, Anderson R, Walter J; Implanted Neuroprosthesis Research Group. An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: a multicenter trial. Arch Phys Med Rehabil. 2001 Nov;82(11):1512-9. doi: 10.1053/apmr.2001.25911.

  PMID: 11689969 BACKGROUND

• Kirkham AP, Knight SL, Craggs MD, Casey AT, Shah PJ. Neuromodulation through sacral nerve roots 2 to 4 with a Finetech-Brindley sacral posterior and anterior root stimulator. Spinal Cord. 2002 Jun;40(6):272-81. doi: 10.1038/sj.sc.3101278.

  PMID: 12037708 BACKGROUND

• Kutzenberger J, Domurath B, Sauerwein D. Spastic bladder and spinal cord injury: seventeen years of experience with sacral deafferentation and implantation of an anterior root stimulator. Artif Organs. 2005 Mar;29(3):239-41. doi: 10.1111/j.1525-1594.2005.29043.x.

  PMID: 15725225 BACKGROUND

• Martens FM, den Hollander PP, Snoek GJ, Koldewijn EL, van Kerrebroeck PE, Heesakkers JP. Quality of life in complete spinal cord injury patients with a Brindley bladder stimulator compared to a matched control group. Neurourol Urodyn. 2011 Apr;30(4):551-5. doi: 10.1002/nau.21012. Epub 2011 Feb 15.

  PMID: 21328472 BACKGROUND

• Martens FM, Heesakkers JP. Clinical results of a brindley procedure: sacral anterior root stimulation in combination with a rhizotomy of the dorsal roots. Adv Urol. 2011;2011:709708. doi: 10.1155/2011/709708. Epub 2011 Jun 22.

  PMID: 21738530 BACKGROUND

• Rasmussen MM, Kutzenberger J, Krogh K, Zepke F, Bodin C, Domurath B, Christensen P. Sacral anterior root stimulation improves bowel function in subjects with spinal cord injury. Spinal Cord. 2015 Apr;53(4):297-301. doi: 10.1038/sc.2015.2. Epub 2015 Jan 20.

  PMID: 25600307 BACKGROUND

• Schurch B, Rodic B, Jeanmonod D. Posterior sacral rhizotomy and intradural anterior sacral root stimulation for treatment of the spastic bladder in spinal cord injured patients. J Urol. 1997 Feb;157(2):610-4.

  PMID: 8996369 BACKGROUND

• van der Aa HE, Alleman E, Nene A, Snoek G. Sacral anterior root stimulation for bladder control: clinical results. Arch Physiol Biochem. 1999 Jul;107(3):248-56. doi: 10.1076/apab.107.3.248.4330.

  PMID: 10650355 BACKGROUND

• Van Kerrebroeck PE, Koldewijn EL, Rosier PF, Wijkstra H, Debruyne FM. Results of the treatment of neurogenic bladder dysfunction in spinal cord injury by sacral posterior root rhizotomy and anterior sacral root stimulation. J Urol. 1996 Apr;155(4):1378-81. doi: 10.1097/00005392-199604000-00069.

  PMID: 8632580 BACKGROUND

• Vastenholt JM, Snoek GJ, Buschman HP, van der Aa HE, Alleman ER, Ijzerman MJ. A 7-year follow-up of sacral anterior root stimulation for bladder control in patients with a spinal cord injury: quality of life and users' experiences. Spinal Cord. 2003 Jul;41(7):397-402. doi: 10.1038/sj.sc.3101465.

  PMID: 12815371 BACKGROUND

• Wielink G, Essink-Bot ML, van Kerrebroeck PE, Rutten FF. Sacral rhizotomies and electrical bladder stimulation in spinal cord injury. 2. Cost-effectiveness and quality of life analysis. Dutch Study Group on Sacral Anterior Root Stimulation. Eur Urol. 1997;31(4):441-6. doi: 10.1159/000474504.

  PMID: 9187905 BACKGROUND

• Kirkham AP, Shah NC, Knight SL, Shah PJ, Craggs MD. The acute effects of continuous and conditional neuromodulation on the bladder in spinal cord injury. Spinal Cord. 2001 Aug;39(8):420-8. doi: 10.1038/sj.sc.3101177.

  PMID: 11512072 BACKGROUND

• Ehsanian R, Creasey G, Elliott CS, Abu-Eid CA, Ali A, Prutton M, Singh H. Implantation of Sacral Nerve Stimulator Without Rhizotomy for Neurogenic Bladder in Patient With Spinal Cord Injury: 2-Dimensional Operative Video. Oper Neurosurg. 2020 Sep 1;19(3):E299. doi: 10.1093/ons/opz429.

  PMID: 31980830 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Graham H. Creasey, MD

  Palo Alto Veterans Institute for Research

  PRINCIPAL INVESTIGATOR

• Reza Ehsanian, MD PhD

  University of New Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 1, 2016
• Study Start: September 1, 2014
• Primary Completion: August 28, 2025
• Study Completion: September 28, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (4)