Spinal Cord InjuryNCT02978638
Electrical Stimulation for Continence After Spinal Cord Injury
A study testing Finetech Vocare Bladder System in people with Spinal Cord Injury and Neurogenic Bladder, run by Palo Alto Veterans Institute for Research at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Bladder, Incontinence
- What is being tested?
- Finetech Vocare Bladder System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to 28 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico
Albuquerque, New Mexico, 87106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Palo Alto Veterans Institute for Research
Palo Alto, California, 94304
Santa Clara Valley Medical Center
San Jose, California, 95128
About this study
Official title: Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block 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 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.
Read the detailed description
Human subjects will be recruited from people with clinically complete spinal cord injury.
Subjects who meet the selection criteria described below will be screened to identify those whose reflex bladder contractions are inhibited by neuromodulation using low levels of electrical stimulation via electrodes on the skin over the dorsal genital nerve. Serial filling cystometries will be performed in the clinical urodynamic laboratories at the study sites. Bladder capacity and compliance will be recorded for each cytometrogram. Subjects whose reflex bladder contractions are significantly inhibited by this neuromodulation will be offered enrollment in the trial. Subjects whose reflex bladder contractions are not significantly inhibited by this neuromodulation, or who do not wish to participate in the study, will be able to continue with their usual form of bladder management.
After screening, selected subjects will be offered surgical implantation of a Vocare Bladder System in the FDA-approved manner, but without posterior rhizotomy. Because posterior rhizotomy is not performed, the afferent axons in the sacral nerves are intact and can be stimulated after surgery via the electrodes connected to the implanted stimulator.
The Vocare Bladder System will be implanted in the FDA-approved manner but without posterior rhizotomy.
After implantation, subjects will be evaluated in the urodynamic laboratory. Stimulation will applied to S34 sacral nerves bilaterally, and the effects on bladder capacity and continence and voiding will be measured.
Continence of urine will be documented by bladder diaries. These diaries will be completed initially as an inpatient in the SCI Service and then at home while applying neuromodulation via the implant.
It is expected that sacral neuromodulation by this method will be associated with a significant increase in bladder capacity and continence.
It is possible that this neuromodulation will not be associated with an increase in bladder capacity or continence. If so, subjects will still be able to use conventional methods of managing continence and should have no loss of function.
Participants whose bladder capacity and continence are improved by neuromodulation using the implanted stimulator will be offered the opportunity to continue to use the stimulator for the duration of the study and will be reviewed at three-month intervals. At the end of the study they will be reviewed again with their usual clinician and if there are no contra-indications to continued use of the stimulator will be offered the opportunity to continue its use under continued clinical follow-up from their usual clinician.
Participants whose bladder capacity and continence are not improved by neuromodulation using the implanted stimulator, or who do not wish to continue using the implanted stimulator, will be reviewed with their usual clinician and offered the bladder management they were using prior to the study. The implanted stimulator will be switched off, but will not be removed unless the participant wishes it to be removed or the investigators or the participant's usual clinician consider it in the participant's interest to be removed. It is usually simpler and safer for the participant to leave the stimulator implanted but inactive.
All participants will be provided with appropriate documentation regarding safety and electromagnetic compatibility of the device.
The investigation is justified because the potential benefits are greater than the potential risks, as follows:
The potential benefit of the research to the subjects are:
- Improved bladder capacity
- Improved continence
The potential benefits of the research to others are:
Evidence that bladder capacity and continence after spinal cord injury can be improved by electrical stimulation without cutting nerves.
The risks to subjects are reasonable in relation to the anticipated benefits to subjects and others because of
- The high prevalence and severity of clinical complications caused by bladder complications after spinal cord injury
- The paucity of methods of restoring continence after spinal cord injury that are safe, effective and without undesirable side effects
This study is primarily aimed at demonstrating safety, feasibility and proof of concept. It may also produce statistically and clinically significant evidence of efficacy that can be used to plan future clinical trials.
Significance:
If the technique of reducing reflex bladder contraction by implanted stimulation of the S34 nerve bilaterally is successful, it will open the door to more effective use of neuromodulation for continence after spinal cord injury.
- Conditions
- Spinal Cord Injury, Neurogenic Bladder, Incontinence
- Being tested
- Finetech Vocare Bladder System
- Keywords
- Spinal cord injury, Bladder capacity, Electrical stimulation, Continence, Urodynamics
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finetech Vocare Bladder SystemDevice
Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Finetech Vocare Bladder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder capacity
Bladder capacity (ml.) measured during filling cystometry
Measured: Change from baseline bladder capacity at 12-month follow-up visit
Secondary outcomes (1)
Frequency of incontinence of urine
Frequency of incontinence determined from diary data collected by the subjects
Measured: Change from baseline frequency of incontinence of urine at 12-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startSep 2014
- Primary completion28 Aug 2025 (estimated)
- Study completion28 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System, Stanford University, Case Western Reserve University, Santa Clara Valley Medical Center, University of New Mexico
- Responsible party
- Principal investigator, Graham Creasey, Palo Alto Veterans Institute for Research
- Investigators
- Graham H. Creasey, MD, Principal investigator, Palo Alto Veterans Institute for ResearchReza Ehsanian, MD PhD, Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978638
- Sponsor's protocol ID
- CRE0004AGG
- Other IDs
- W81XWH-14-2-0132
- Status last verified
- Jul 2025
- First submitted
- 22 Nov 2016
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 11689969Kirkham 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.
PubMed 12037708Kutzenberger 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.
PubMed 15725225Martens 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.
PubMed 21328472Martens 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.
PubMed 21738530Rasmussen 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.
PubMed 25600307Schurch 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.
PubMed 8996369van 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.
PubMed 10650355Van 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.
PubMed 8632580Vastenholt 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.
PubMed 12815371Wielink 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.
PubMed 9187905Kirkham 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.
PubMed 11512072Ehsanian 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.
PubMed 31980830
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02978638
- Acronym / sponsor ID
- CRE0004AGG
- Conditions
- Spinal Cord Injury, Neurogenic Bladder, Incontinence
- Keywords
- Spinal cord injury, Bladder capacity, Electrical stimulation, Continence, Urodynamics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System, Stanford University, Case Western Reserve University, Santa Clara Valley Medical Center, University of New Mexico
- Study start
- Sep 2014
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 28 Sep 2025 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Human subjects will be recruited from people with clinically complete spinal cord injury.
Subjects who meet the selection criteria described below will be screened to identify those whose reflex bladder contractions are inhibited by neuromodulation using low levels of electrical stimulation via electrodes on the skin over the dorsal genital nerve. Serial filling cystometries will be performed in the clinical urodynamic laboratories at the study sites. Bladder capacity and compliance will be recorded for each cytometrogram. Subjects whose reflex bladder contractions are significantly inhibited by this neuromodulation will be offered enrollment in the trial. Subjects whose reflex bladder contractions are not significantly inhibited by this neuromodulation, or who do not wish to participate in the study, will be able to continue with their usual form of bladder management.
After screening, selected subjects will be offered surgical implantation of a Vocare Bladder System in the FDA-approved manner, but without posterior rhizotomy. Because posterior rhizotomy is not performed, the afferent axons in the sacral nerves are intact and can be stimulated after surgery via the electrodes connected to the implanted stimulator.
The Vocare Bladder System will be implanted in the FDA-approved manner but without posterior rhizotomy.
After implantation, subjects will be evaluated in the urodynamic laboratory. Stimulation will applied to S34 sacral nerves bilaterally, and the effects on bladder capacity and continence and voiding will be measured.
Continence of urine will be documented by bladder diaries. These diaries will be completed initially as an inpatient in the SCI Service and then at home while applying neuromodulation via the implant.
It is expected that sacral neuromodulation by this method will be associated with a significant increase in bladder capacity and continence.
It is possible that this neuromodulation will not be associated with an increase in bladder capacity or continence. If so, subjects will still be able to use conventional methods of managing continence and should have no loss of function.
Participants whose bladder capacity and continence are improved by neuromodulation using the implanted stimulator will be offered the opportunity to continue to use the stimulator for the duration of the study and will be reviewed at three-month intervals. At the end of the study they will be reviewed again with their usual clinician and if there are no contra-indications to continued use of the stimulator will be offered the opportunity to continue its use under continued clinical follow-up from their usual clinician.
Participants whose bladder capacity and continence are not improved by neuromodulation using the implanted stimulator, or who do not wish to continue using the implanted stimulator, will be reviewed with their usual clinician and offered the bladder management they were using prior to the study. The implanted stimulator will be switched off, but will not be removed unless the participant wishes it to be removed or the investigators or the participant's usual clinician consider it in the participant's interest to be removed. It is usually simpler and safer for the participant to leave the stimulator implanted but inactive.
All participants will be provided with appropriate documentation regarding safety and electromagnetic compatibility of the device.
The investigation is justified because the potential benefits are greater than the potential risks, as follows:
The potential benefit of the research to the subjects are:
- Improved bladder capacity
- Improved continence
The potential benefits of the research to others are:
Evidence that bladder capacity and continence after spinal cord injury can be improved by electrical stimulation without cutting nerves.
The risks to subjects are reasonable in relation to the anticipated benefits to subjects and others because of
- The high prevalence and severity of clinical complications caused by bladder complications after spinal cord injury
- The paucity of methods of restoring continence after spinal cord injury that are safe, effective and without undesirable side effects
This study is primarily aimed at demonstrating safety, feasibility and proof of concept. It may also produce statistically and clinically significant evidence of efficacy that can be used to plan future clinical trials.
Significance:
If the technique of reducing reflex bladder contraction by implanted stimulation of the S34 nerve bilaterally is successful, it will open the door to more effective use of neuromodulation for continence after spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finetech Vocare Bladder System | Other | Device: Finetech Vocare Bladder SystemThis 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finetech Vocare Bladder SystemParticipants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes. | Device | Finetech Vocare Bladder System |
Primary outcome
Bladder capacity
Time frame: Change from baseline bladder capacity at 12-month follow-up visit
Bladder capacity (ml.) measured during filling cystometry
1 secondary outcome
Frequency of incontinence of urine
Time frame: Change from baseline frequency of incontinence of urine at 12-month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 11689969Creasey 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.
- Background: PubMed 12037708Kirkham 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.
- Background: PubMed 15725225Kutzenberger 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.
- Background: PubMed 21328472Martens 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.
- Background: PubMed 21738530Martens 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.
- Background: PubMed 25600307Rasmussen 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.
- Background: PubMed 8996369Schurch 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.
- Background: PubMed 10650355van 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.
- Background: PubMed 8632580Van 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.
- Background: PubMed 12815371Vastenholt 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.
- Background: PubMed 9187905Wielink 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.
- Background: PubMed 11512072Kirkham 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham H. Creasey, MD principal investigator
Palo Alto Veterans Institute for Research
Reza Ehsanian, MD PhD study director
University of New Mexico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finetech Vocare Bladder System in people with Spinal Cord Injury and Neurogenic Bladder, run by Palo Alto Veterans Institute for Research at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder capacity (time frame: Change from baseline bladder capacity at 12-month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978638, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.