Lumbar to Sacral Ventral Nerve Re-Routing

Urinary Incontinence Clinical Trial

Official title:

Lumbar to Sacral Ventral Nerve Re-Routing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378664
• Other study ID #: 2006-124
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2006
• Last updated: October 13, 2015
• Start date: September 2006
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spina Bifida
• Spinal Cord Injuries
• Spinal Cord Injury
• Spinal Dysraphism
• Urinary Incontinence

Intervention

Procedure:
• lumbar to sacral ventral nerve re-routing procedure
surgical nerve re-routing procedure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Peters, MD	William Beaumont Hospitals

References & Publications (4)

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. — View 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. — View Citation

Müller 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. Review. — View 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. Epub 2005 Nov 2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No