Lumbar to Sacral Ventral Nerve Re-Routing
Primary Purpose
Urinary Incontinence, Spinal Cord Injury, Spina Bifida
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
lumbar to sacral ventral nerve re-routing procedure
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, spinal cord injury, spina bifida
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
Outcomes
Primary Outcome Measures
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.
Secondary Outcome Measures
Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients
Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients
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
Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older
Full Information
NCT ID
NCT00378664
First Posted
September 19, 2006
Last Updated
October 13, 2015
Sponsor
Kenneth Peters, MD
Collaborators
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00378664
Brief Title
Lumbar to Sacral Ventral Nerve Re-Routing
Official Title
Lumbar to Sacral Ventral Nerve Re-Routing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
Collaborators
William Beaumont Hospitals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Spinal Cord Injury, Spina Bifida
Keywords
urinary incontinence, spinal cord injury, spina bifida
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
Intervention Type
Procedure
Intervention Name(s)
lumbar to sacral ventral nerve re-routing procedure
Intervention Description
surgical nerve re-routing procedure
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Peters, M.D.
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16314037
Citation
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.
Results Reference
background
PubMed Identifier
16029629
Citation
Liu 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.
Results Reference
background
PubMed Identifier
12353510
Citation
Mathews 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.
Results Reference
background
PubMed Identifier
12409876
Citation
Muller 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.
Results Reference
background
PubMed Identifier
24987412
Citation
Peters 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.
Results Reference
derived
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Lumbar to Sacral Ventral Nerve Re-Routing
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