Urinary IncontinencePhase 2NCT00378664
Lumbar to Sacral Ventral Nerve Re-Routing
A Phase 2 study testing lumbar to sacral ventral nerve re-routing procedure in people with Urinary Incontinence and Spinal Cord Injury, run by Kenneth Peters, MD.
Trial summary
To assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in Spinal Cord Injury and spina bifida patients Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Spinal Cord Injury, Spina Bifida
- What is being tested?
- lumbar to sacral ventral nerve re-routing procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jan 2015
- Phase
- Phase 2
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female paraplegics 18 years and older with spinal cord lesion above L1 on a CIC program for bladder management and a score of "A" on ASIA scale.
- Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management.
- Neurogenic bladder documented by urodynamic testing.
- Stable neurogenic bladder dysfunction of at least 1 year or more.
- Compliant bladder wall.
- Normal renal function.
Who cannot join
- History of bladder cancer, augmentation, or radiation.
- Bladder capacity less than 100 milliliters (ml).
- Anatomic outlet obstruction or urethral strictures.
- Vesico-ureteric reflux grade 2 or higher.
- Presence of an ileal conduit or supra-pubic catheter drainage.
- Contraindications to general anesthesia or surgery.
- Inability to complete follow up visits for 3 years.
- Inability to comprehend and answer self-administered questionnaires.
About this study
To assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in Spinal Cord Injury and spina bifida patients
Read the detailed description
Spinal cord injury (SCI) and spina bifida is a source of irreversible injury to the spinal cord often resulting in paralysis and loss of sensation below the waist. The inability to urinate normally is a consequence of both conditions (neurogenic voiding dysfunction). In spina bifida and spinal cord injury, the nerve that controls the bladder and sphincter (the muscle that squeezes the bladder neck to prevent leaking) may no longer work properly resulting in patients who cannot urinate or are constantly wet.
Most patients will maintain high pressures in their bladder and these elevated pressures will eventually take its toll by causing recurrent urinary tract infections, backup of urine to the kidneys, and marked dilatation of possible further damage to the kidneys. Many patients eventually suffer from irreversible renal (kidney) damage, where dialysis or kidney transplant is the only way to sustain life.
Spinal bifida (present at birth) and SCI (occurs most often early in the fourth decade of life) predominately affect young individuals and longevity and quality of life may be greatly reduced by the presence of bladder, bowel, and sexual dysfunction. In the recent past, medications and catheters were the only way to help cord injured patients empty their bladders. Although clean intermittent catheterization (CIC) provides good maintenance results, medications can help conserve low bladder pressures, and antibiotics sustain an infection free urinary tract, these are difficult bladder management programs to uphold. They are expensive, time consuming, and outcomes are inconsistent.
A new surgical procedure has potential for treatment of spinal cord injuries/ spinal bifida. Recently, Dr. Chuan-Guo Xiao from China developed a surgical procedure of rewiring the nerves in the spinal cord to gain better control of urination and avoid complications of neurogenic bladder. The procedure reconnects live wires (nerves) to dead wires.
- Conditions
- Urinary Incontinence, Spinal Cord Injury, Spina Bifida
- Being tested
- lumbar to sacral ventral nerve re-routing procedure
- Keywords
- urinary incontinence, spinal cord injury, spina bifida
- Medical subject headings
- Urinary Incontinence, Spinal Cord Injuries, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar to sacral ventral nerve re-routing procedureProcedure or surgery
surgical nerve re-routing procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure. Receives: Procedure: lumbar to sacral ventral nerve re-routing procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.
Measured: evaluated at 6 months and 1 year
Secondary outcomes (4)
Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients
Measured: evaluated at 6 month and 1 year visit
Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients
Measured: evaluate at 6 month and 1 year
Assess the effect of the lumbar to sacral ventral nerve re-routing on ability to perform activities of daily living in SCI and spina bifida patients
Measured: evaluate at 6 month and 1 year visit
Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older
Measured: evaluate at 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, M.D., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378664
- Sponsor's protocol ID
- 2006-124
- Status last verified
- Oct 2015
- First submitted
- 19 Sep 2006
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiao CG. Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida. Eur Urol. 2006 Jan;49(1):22-8; discussion 28-9. doi: 10.1016/j.eururo.2005.10.004. Epub 2005 Nov 2.
PubMed 16314037Liu Z, Liu CJ, Hu XW, Du MX, Xiao CG. [An electrophysiological study on the artificial somato-autonomic pathway for inducing voiding]. Zhonghua Yi Xue Za Zhi. 2005 May 25;85(19):1315-8. Chinese.
PubMed 16029629Mathews TJ, Honein MA, Erickson JD. Spina bifida and anencephaly prevalence--United States, 1991-2001. MMWR Recomm Rep. 2002 Sep 13;51(RR-13):9-11.
PubMed 12353510Muller T, Arbeiter K, Aufricht C. Renal function in meningomyelocele: risk factors, chronic renal failure, renal replacement therapy and transplantation. Curr Opin Urol. 2002 Nov;12(6):479-84. doi: 10.1097/00042307-200211000-00006.
PubMed 12409876Peters KM, Gilmer H, Feber K, Girdler BJ, Nantau W, Trock G, Killinger KA, Boura JA. US Pilot Study of Lumbar to Sacral Nerve Rerouting to Restore Voiding and Bowel Function in Spina Bifida: 3-Year Experience. Adv Urol. 2014;2014:863209. doi: 10.1155/2014/863209. Epub 2014 Jun 2.
PubMed 24987412
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar to Sacral Ventral Nerve Re-Routing
- ClinicalTrials.gov ID
- NCT00378664
- Acronym / sponsor ID
- 2006-124
- Conditions
- Urinary Incontinence, Spinal Cord Injury, Spina Bifida
- Keywords
- urinary incontinence, spinal cord injury, spina bifida
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Sep 2006
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Sep 2006 (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.
To assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in Spinal Cord Injury and spina bifida patients
Detailed description
Spinal cord injury (SCI) and spina bifida is a source of irreversible injury to the spinal cord often resulting in paralysis and loss of sensation below the waist. The inability to urinate normally is a consequence of both conditions (neurogenic voiding dysfunction). In spina bifida and spinal cord injury, the nerve that controls the bladder and sphincter (the muscle that squeezes the bladder neck to prevent leaking) may no longer work properly resulting in patients who cannot urinate or are constantly wet.
Most patients will maintain high pressures in their bladder and these elevated pressures will eventually take its toll by causing recurrent urinary tract infections, backup of urine to the kidneys, and marked dilatation of possible further damage to the kidneys. Many patients eventually suffer from irreversible renal (kidney) damage, where dialysis or kidney transplant is the only way to sustain life.
Spinal bifida (present at birth) and SCI (occurs most often early in the fourth decade of life) predominately affect young individuals and longevity and quality of life may be greatly reduced by the presence of bladder, bowel, and sexual dysfunction. In the recent past, medications and catheters were the only way to help cord injured patients empty their bladders. Although clean intermittent catheterization (CIC) provides good maintenance results, medications can help conserve low bladder pressures, and antibiotics sustain an infection free urinary tract, these are difficult bladder management programs to uphold. They are expensive, time consuming, and outcomes are inconsistent.
A new surgical procedure has potential for treatment of spinal cord injuries/ spinal bifida. Recently, Dr. Chuan-Guo Xiao from China developed a surgical procedure of rewiring the nerves in the spinal cord to gain better control of urination and avoid complications of neurogenic bladder. The procedure reconnects live wires (nerves) to dead wires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: lumbar to sacral ventral nerve re-routing procedureAll enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female paraplegics 18 years and older with spinal cord lesion above L1 on a CIC program for bladder management and a score of "A" on ASIA scale.
- Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management.
- Neurogenic bladder documented by urodynamic testing.
- Stable neurogenic bladder dysfunction of at least 1 year or more.
- Compliant bladder wall.
Key exclusion criteria (8 listed)
- History of bladder cancer, augmentation, or radiation.
- Bladder capacity less than 100 milliliters (ml).
- Anatomic outlet obstruction or urethral strictures.
- Vesico-ureteric reflux grade 2 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 |
|---|---|---|
| lumbar to sacral ventral nerve re-routing proceduresurgical nerve re-routing procedure | Procedure or surgery | Intervention |
Primary outcome
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.
Time frame: evaluated at 6 months and 1 year
4 secondary outcomes
Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients
Time frame: evaluated at 6 month and 1 year visit
Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients
Time frame: evaluate at 6 month and 1 year
Assess the effect of the lumbar to sacral ventral nerve re-routing on ability to perform activities of daily living in SCI and spina bifida patients
Time frame: evaluate at 6 month and 1 year visit
Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older
Time frame: evaluate at 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 16314037Xiao CG. Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida. Eur Urol. 2006 Jan;49(1):22-8; discussion 28-9. doi: 10.1016/j.eururo.2005.10.004. Epub 2005 Nov 2.
- Background: PubMed 16029629Liu Z, Liu CJ, Hu XW, Du MX, Xiao CG. [An electrophysiological study on the artificial somato-autonomic pathway for inducing voiding]. Zhonghua Yi Xue Za Zhi. 2005 May 25;85(19):1315-8. Chinese.
- Background: PubMed 12353510Mathews TJ, Honein MA, Erickson JD. Spina bifida and anencephaly prevalence--United States, 1991-2001. MMWR Recomm Rep. 2002 Sep 13;51(RR-13):9-11.
- Background: PubMed 12409876Muller T, Arbeiter K, Aufricht C. Renal function in meningomyelocele: risk factors, chronic renal failure, renal replacement therapy and transplantation. Curr Opin Urol. 2002 Nov;12(6):479-84. doi: 10.1097/00042307-200211000-00006.
- Derived from this study: PubMed 24987412Peters KM, Gilmer H, Feber K, Girdler BJ, Nantau W, Trock G, Killinger KA, Boura JA. US Pilot Study of Lumbar to Sacral Nerve Rerouting to Restore Voiding and Bowel Function in Spina Bifida: 3-Year Experience. Adv Urol. 2014;2014:863209. doi: 10.1155/2014/863209. Epub 2014 Jun 2.
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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 M Peters, M.D. principal investigator
Corewell Health East
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lumbar to sacral ventral nerve re-routing procedure in people with Urinary Incontinence and Spinal Cord Injury, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 14 Oct 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients. (time frame: evaluated at 6 months and 1 year). 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 NCT00378664, which also lists 5 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 14 Oct 2015.