Lumbar to Sacral Ventral Nerve Re-Routing

Phase 2

Completed

• Conditions: Spina Bifida; Urinary Incontinence; Spinal Cord Injury
• Interventions: Procedure: lumbar to sacral ventral nerve re-routing procedure

• Registration Number: NCT00378664
• Lead Sponsor: Kenneth Peters, MD

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-21
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	lumbar to sacral ventral nerve re-routing procedure	All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.

Primary Outcome Measures

Name	Time	Method
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.	evaluated at 6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients	evaluate at 6 month and 1 year
Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients	evaluated at 6 month and 1 year visit
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	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	evaluate at 6 months and 1 year