Electrical Stimulation for Continence After Spinal Cord Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Hospital, Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 11/18/2018 |
| Start Date: | September 2014 |
| End Date: | September 2019 |
| Contact: | Graham H. Creasey, MD |
| Phone: | 650-493-5000 |
Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
This study aims to improve continence 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.
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.
Human subjects will be recruited at the VA Palo Alto Health Care System 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 laboratory in the Spinal
Cord Injury Service of the VA Palo Alto. 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
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:
1. Improved bladder capacity
2. 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
1. The high prevalence and severity of clinical complications caused by bladder
complications after spinal cord injury
2. 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.
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 laboratory in the Spinal
Cord Injury Service of the VA Palo Alto. 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
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:
1. Improved bladder capacity
2. 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
1. The high prevalence and severity of clinical complications caused by bladder
complications after spinal cord injury
2. 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.
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. The criteria for DESD diagnosis will be the presence of an
open bladder neck without stress incontinence, with a closed external urethral
sphincter during the filling or voiding phase of fluoroscopic assisted urodynamic
studies.
- 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
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