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
  Purpose

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


Condition Intervention Phase
Urinary Incontinence
Spinal Cord Injury
Spina Bifida
Procedure: lumbar to sacral ventral nerve re-routing procedure
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lumbar to Sacral Ventral Nerve Re-Routing

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

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. [ Time Frame: evaluated at 6 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: September 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
Procedure: lumbar to sacral ventral nerve re-routing procedure
surgical nerve re-routing procedure

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378664

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth M Peters, M.D. William Beaumont Hospitals
  More Information

Publications:
Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00378664     History of Changes
Other Study ID Numbers: 2006-124
Study First Received: September 19, 2006
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
urinary incontinence
spinal cord injury
spina bifida

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Dysraphism
Urinary Incontinence
Central Nervous System Diseases
Congenital Abnormalities
Lower Urinary Tract Symptoms
Nervous System Diseases
Nervous System Malformations
Neural Tube Defects
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Urination Disorders
Urologic Diseases
Urological Manifestations
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014