Lumbar to Sacral Ventral Nerve Re-Routing - Full Text View

Sponsored by:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00378664

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 II

MedlinePlus related topics: Spina Bifida Spinal Cord Injuries Urinary Incontinence Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Lumbar to Sacral Ventral Nerve Re-Routing

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:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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

Exclusion Criteria:

History of bladder cancer, augmentation, or radiation.
Bladder capacity less than 100 milliliters (ml).
Anatomic outlet obstruction or urethral strictures.
Vesico-ureteric reflux grade 2 or higher.
Presence of an ileal conduit or supra-pubic catheter drainage.
Contraindications to general anesthesia or surgery.
Inability to complete follow up visits for 3 years.
Inability to comprehend and answer self-administered questionnaires.

Contacts and Locations

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

Contacts

Contact: Cindy Turzewski, RN

248-551-3565

Locations

United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Cindy Turzewski, RN 248-551-3565
Sub-Investigator: Kenneth Peters, MD

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Ananias Diokno, M.D.

William Beaumont Hospitals

More Information

Publications:

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.

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.

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.

Muller 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.

Responsible Party:	William Beaumont Hospital ( Kenneth Peters )
Study ID Numbers:	2006-124
Study First Received:	September 19, 2006
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00378664
Health Authority:	United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

urinary incontinence
spinal cord injury
spina bifida

Study placed in the following topic categories:

Neural Tube Defects
Spinal Cord Diseases
Spinal Dysraphism
Urination Disorders
Nervous System Malformations
Spina bifida
Wounds and Injuries
Central Nervous System Diseases

Disorders of Environmental Origin
Trauma, Nervous System
Spinal Cord Injuries
Signs and Symptoms
Urologic Diseases
Neural tube defect, folate-sensitive
Urinary Incontinence
Congenital Abnormalities

Additional relevant MeSH terms:

Urological Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009