Lumbar to Sacral Ventral Nerve Re-Routing

NCT00378664 | Completed Phase 2 DMC

• 1 other identifier: 2006-124
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urinary Incontinence; Spinal Cord Injury; Spina Bifida

Keywords

urinary incontinence; spinal cord injury; spina bifida

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 health related quality of life in SCI and spina bifida patients

  evaluate at 6 month and 1 year

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

lumbar to sacral ventral nerve re-routing procedure PROCEDURE

surgical nerve re-routing procedure

Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenneth Peters, MD: lead
• Corewell Health East: collaborator

Related Publications (5)

• 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.

  PMID: 16314037 BACKGROUND

• 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.

  PMID: 16029629 BACKGROUND

• 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.

  PMID: 12353510 BACKGROUND

• 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.

  PMID: 12409876 BACKGROUND

• 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.

  PMID: 24987412 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Spinal Cord Injuries; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kenneth M Peters, M.D.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10