Lumbar to Sacral Ventral Nerve Re-Routing

• ClinicalTrials.gov Identifier: NCT00378664
• Recruitment Status: Completed
• First Posted: September 21, 2006
• Last Update Posted: October 14, 2015
• Sponsor: Kenneth Peters, MD
• Collaborator: William Beaumont Hospitals
• Information provided by (Responsible Party): Kenneth Peters, MD, William Beaumont Hospitals

Study Description

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

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lumbar to Sacral Ventral Nerve Re-Routing
• Study Start Date: September 2006
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Kenneth Peters, MD

William Beaumont Hospitals

Investigators

• Principal Investigator: Kenneth M Peters, 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. doi: 10.1016/j.eururo.2005.10.004. Epub 2005 Nov 2.

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. doi: 10.1097/00042307-200211000-00006.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peters KM, Gilmer H, Feber K, Girdler BJ, Nantau W, Trock G, Killinger KA, Boura JA. US Pilot Study of Lumbar to Sacral Nerve Rerouting to Restore Voiding and Bowel Function in Spina Bifida: 3-Year Experience. Adv Urol. 2014;2014:863209. doi: 10.1155/2014/863209. Epub 2014 Jun 2.

• Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT00378664
• Other Study ID Numbers: 2006-124
• First Posted: September 21, 2006
• Last Update Posted: October 14, 2015
• Last Verified: October 2015

Keywords provided by Kenneth Peters, MD, William Beaumont Hospitals:

urinary incontinence; spinal cord injury; spina bifida

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Dysraphism; Urinary Incontinence; Enuresis; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities