Spina BifidaNCT01096459
Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida
A study testing Nerve Rerouting in people with Spina Bifida, run by Kenneth Peters, MD.
Trial summary
The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar to sacral nerves in the spinal column to improve the bladder's ability to empty properly in patients born with Spina Bifida. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Nerve Rerouting
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients age 5 and older with spinal dysraphism (ie. myelomeningocele , lipomyelomeningocele, myelocele, meningocele, occulta) with voiding dysfunction on a CIC program for bladder management for at least one year prior to screening.
- Atonic or hyperreflexic bladder documented by urodynamic testing during screening. .
- Documented history of no more than one tethered cord surgery/release in the past; must be > 2 years post tethered cord surgery/release
- Stable neurogenic bladder dysfunction of at least 1 year or more
- Normal renal function (cr<1.5 mg/dl or GFR >75)
- Ambulate independently with or without ankle-foot orthotics (AFOs).
- Catheterized volume must be at least 50% of total bladder capacity.
Who cannot join
- History of bladder cancer, augmentation, or radiation
- Anatomic outlet obstruction or urethral strictures
- History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT
- Hydronephrosis grade 3 or higher
- Presence of an ileal conduit or supra-pubic catheter drainage
- Subjects with an artificial bladder sphincter
Show all 16Show fewer
- Subjects who have had a sling procedure
- Subjects who have had the mitrofanoff procedure
- Bladder botox injections within last 12 months
- Spina Bifida subjects who underwent intrauterine closure of their myelomeningocele
- Unable to ambulate independently with or without AFOs.
- Subject is pregnant
- Contraindications to general anesthesia or surgery
- Inability to complete follow up visits for 2 years
- Inability to complete (or have parent complete) self administered questionnaires
- Subject possesses any other characteristics that, per investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.
About this study
Official title: Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida
The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar to sacral nerves in the spinal column to improve the bladder's ability to empty properly in patients born with Spina Bifida.
Read the detailed description
Spina Bifida (a congenital defect of the spinal cord), causes nerve damage and a loss of sensation and muscle function below the waist resulting in bowel and bladder dysfunction. Patients cannot urinate or are constantly wet, and this continues throughout life causing major quality of life and health problems. Clean intermittent catheterization (draining urine from the bladder with a tube) is usually needed to empty the bladder properly. Medications are routinely required to alleviate high urinary tract pressures that can cause irreversible kidney damage, where dialysis or kidney transplant is the only way to sustain life.
A Chinese urologist developed a novel procedure to connect a functioning, healthy lumbar spinal nerve to the sacral nerve that controls the bladder. Hundreds of these procedures have been done in China. The end result is the creation of a new reflex where the bladder can be emptied by scratching or stimulating the skin (over the hip or thigh) supplied by that spinal nerve root. The Chinese physician had reported that of 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, the reported success was 87% at one year. However, in China rigorous follow up is challenging, therefore much is still unknown about how the nerves regenerate post surgery, complications and results occurring in the first year in particular, and the potential role that central nervous system remodeling may play in achieving successful outcomes. Beaumont urologists were the first in the US to perform this surgery on children with spina bifida. Our preliminary data are very promising, and in 9 subjects at 12 months post procedure, 7/9 subjects could void either voluntarily or by stimulating the new reflex mechanism.
This current project aims to expand upon our pilot experience to conduct a larger and more rigorous study to establish the safety and effectiveness of the proposed somatic-autonomic reflex pathway procedure in gaining bladder and bowel control in patients with spina bifida. We will also collaborate with and train investigators at another site(s) to determine the training needed to achieve similar safety and effectiveness outcomes, and evaluate possible methods to stimulate the new reflex to improve bladder emptying. Achieving the aims outlined in this multicenter proposal will help firmly establish the procedure as safe and effective, and revolutionize the treatment of bladder and bowel dysfunction in patients with spina bifida in the US.
- Conditions
- Spina Bifida
- Being tested
- Nerve Rerouting
- Keywords
- spina, bifida, restore, urinary, function, nerve, reroute
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve ReroutingProcedure or surgery
All subjects will receive the unilateral nerve rerouting procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducible bladder contraction
The primary aim of this study is reproducible bladder contraction of 15cm/H20 or more with scratching the cutaneous dermatome and no significant contraction with stimulation of the non-operated side.
Measured: 6 to 24 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Protocol as presented by investigator was not approved by the NIDDK.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096459
- Sponsor's protocol ID
- 2010-029
- Other IDs
- R01DK084034
- Status last verified
- Jul 2013
- First submitted
- 23 Mar 2010
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida
- ClinicalTrials.gov ID
- NCT01096459
- Acronym / sponsor ID
- 2010-029
- Conditions
- Spina Bifida
- Keywords
- spina, bifida, restore, urinary, function, nerve, reroute
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol as presented by investigator was not approved by the NIDDK.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Mar 2010 (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.
The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar to sacral nerves in the spinal column to improve the bladder's ability to empty properly in patients born with Spina Bifida.
Detailed description
Spina Bifida (a congenital defect of the spinal cord), causes nerve damage and a loss of sensation and muscle function below the waist resulting in bowel and bladder dysfunction. Patients cannot urinate or are constantly wet, and this continues throughout life causing major quality of life and health problems. Clean intermittent catheterization (draining urine from the bladder with a tube) is usually needed to empty the bladder properly. Medications are routinely required to alleviate high urinary tract pressures that can cause irreversible kidney damage, where dialysis or kidney transplant is the only way to sustain life.
A Chinese urologist developed a novel procedure to connect a functioning, healthy lumbar spinal nerve to the sacral nerve that controls the bladder. Hundreds of these procedures have been done in China. The end result is the creation of a new reflex where the bladder can be emptied by scratching or stimulating the skin (over the hip or thigh) supplied by that spinal nerve root. The Chinese physician had reported that of 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, the reported success was 87% at one year. However, in China rigorous follow up is challenging, therefore much is still unknown about how the nerves regenerate post surgery, complications and results occurring in the first year in particular, and the potential role that central nervous system remodeling may play in achieving successful outcomes. Beaumont urologists were the first in the US to perform this surgery on children with spina bifida. Our preliminary data are very promising, and in 9 subjects at 12 months post procedure, 7/9 subjects could void either voluntarily or by stimulating the new reflex mechanism.
This current project aims to expand upon our pilot experience to conduct a larger and more rigorous study to establish the safety and effectiveness of the proposed somatic-autonomic reflex pathway procedure in gaining bladder and bowel control in patients with spina bifida. We will also collaborate with and train investigators at another site(s) to determine the training needed to achieve similar safety and effectiveness outcomes, and evaluate possible methods to stimulate the new reflex to improve bladder emptying. Achieving the aims outlined in this multicenter proposal will help firmly establish the procedure as safe and effective, and revolutionize the treatment of bladder and bowel dysfunction in patients with spina bifida in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients age 5 and older with spinal dysraphism (ie. myelomeningocele , lipomyelomeningocele, myelocele, meningocele, occulta) with voiding dysfunction on a CIC program for bladder management for at least one year prior to screening.
- Atonic or hyperreflexic bladder documented by urodynamic testing during screening. .
- Documented history of no more than one tethered cord surgery/release in the past; must be > 2 years post tethered cord surgery/release
- Stable neurogenic bladder dysfunction of at least 1 year or more
- Normal renal function (cr<1.5 mg/dl or GFR >75)
Key exclusion criteria (16 listed)
- History of bladder cancer, augmentation, or radiation
- Anatomic outlet obstruction or urethral strictures
- History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT
- Hydronephrosis grade 3 or higher
- Presence of an ileal conduit or supra-pubic catheter drainage
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 |
|---|---|---|
| Nerve ReroutingAll subjects will receive the unilateral nerve rerouting procedure. | Procedure or surgery | – |
Primary outcome
Reproducible bladder contraction
Time frame: 6 to 24 months post procedure
The primary aim of this study is reproducible bladder contraction of 15cm/H20 or more with scratching the cutaneous dermatome and no significant contraction with stimulation of the non-operated side.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
Related trials for Spina Bifida
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Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
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Parenting Program for Young Children With Spina Bifida
Spina Bifida
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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
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Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
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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.
Kenneth Peters, MD principal investigator
Corewell Health East
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Rerouting in people with Spina Bifida, run by Kenneth Peters, MD.
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 7 inclusion and 16 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: withdrawn, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reproducible bladder contraction (time frame: 6 to 24 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2013.