Lumbar to Sacral Ventral Nerve Re-Routing

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00378664
First received: September 19, 2006
Last updated: May 12, 2014
Last verified: May 2014

September 19, 2006
May 12, 2014
September 2006
December 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.
Complete list of historical versions of study NCT00378664 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Lumbar to Sacral Ventral Nerve Re-Routing
Lumbar to Sacral Ventral Nerve Re-Routing

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Urinary Incontinence
  • Spinal Cord Injury
  • Spina Bifida
Procedure: lumbar to sacral ventral nerve re-routing procedure
surgical nerve re-routing procedure
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
6 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00378664
2006-124
Yes
Kenneth Peters, MD, William Beaumont Hospitals
Kenneth Peters, MD
William Beaumont Hospitals
Principal Investigator: Kenneth M Peters, M.D. William Beaumont Hospitals
William Beaumont Hospitals
May 2014

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