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Lumbar to Sacral Ventral Nerve Re-Routing

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ClinicalTrials.gov Identifier: NCT00378664
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE September 19, 2006
First Posted Date  ICMJE September 21, 2006
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE September 2006
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar to Sacral Ventral Nerve Re-Routing
Official Title  ICMJE Lumbar to Sacral Ventral Nerve Re-Routing
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Incontinence
  • Spinal Cord Injury
  • Spina Bifida
Intervention  ICMJE Procedure: lumbar to sacral ventral nerve re-routing procedure
surgical nerve re-routing procedure
Study Arms  ICMJE Experimental: Intervention
All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
Intervention: Procedure: lumbar to sacral ventral nerve re-routing procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2015)
13
Original Enrollment  ICMJE
 (submitted: September 19, 2006)
12
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management.
  3. Neurogenic bladder documented by urodynamic testing.
  4. Stable neurogenic bladder dysfunction of at least 1 year or more.
  5. Compliant bladder wall.
  6. Normal renal function.

Exclusion Criteria:

  1. History of bladder cancer, augmentation, or radiation.
  2. Bladder capacity less than 100 milliliters (ml).
  3. Anatomic outlet obstruction or urethral strictures.
  4. Vesico-ureteric reflux grade 2 or higher.
  5. Presence of an ileal conduit or supra-pubic catheter drainage.
  6. Contraindications to general anesthesia or surgery.
  7. Inability to complete follow up visits for 3 years.
  8. Inability to comprehend and answer self-administered questionnaires.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00378664
Other Study ID Numbers  ICMJE 2006-124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Peters, MD, William Beaumont Hospitals
Study Sponsor  ICMJE Kenneth Peters, MD
Collaborators  ICMJE William Beaumont Hospitals
Investigators  ICMJE
Principal Investigator: Kenneth M Peters, M.D. William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP