Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida

NCT01096459 | Withdrawn DMC

• 2 other identifiers: 2010-029R01DK084034
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar to sacral nerves in the spinal column to improve the bladder's ability to empty properly in patients born with Spina Bifida.

Conditions

Spina Bifida

Keywords

spina; bifida; restore; urinary; function; nerve; reroute

Outcome Measures

Primary Outcomes (1)

• Reproducible bladder contraction

  The primary aim of this study is reproducible bladder contraction of 15cm/H20 or more with scratching the cutaneous dermatome and no significant contraction with stimulation of the non-operated side.

  6 to 24 months post procedure

Interventions

Nerve Rerouting PROCEDURE

All subjects will receive the unilateral nerve rerouting procedure.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients age 5 and older with spinal dysraphism (ie. myelomeningocele , lipomyelomeningocele, myelocele, meningocele, occulta) with voiding dysfunction on a CIC program for bladder management for at least one year prior to screening.
• Atonic or hyperreflexic bladder documented by urodynamic testing during screening. .
• Documented history of no more than one tethered cord surgery/release in the past; must be \> 2 years post tethered cord surgery/release
• Stable neurogenic bladder dysfunction of at least 1 year or more
• Normal renal function (cr\<1.5 mg/dl or GFR \>75)
• Ambulate independently with or without ankle-foot orthotics (AFOs).
• Catheterized volume must be at least 50% of total bladder capacity.

You may not qualify if:

• History of bladder cancer, augmentation, or radiation
• Anatomic outlet obstruction or urethral strictures
• History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT
• Hydronephrosis grade 3 or higher
• Presence of an ileal conduit or supra-pubic catheter drainage
• Subjects with an artificial bladder sphincter
• Subjects who have had a sling procedure
• Subjects who have had the mitrofanoff procedure
• Bladder botox injections within last 12 months
• Spina Bifida subjects who underwent intrauterine closure of their myelomeningocele
• Unable to ambulate independently with or without AFOs.
• Subject is pregnant
• Contraindications to general anesthesia or surgery
• Inability to complete follow up visits for 2 years
• Inability to complete (or have parent complete) self administered questionnaires

Sponsors & Collaborators

• Kenneth Peters, MD: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kenneth Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: March 23, 2010
• First Posted: March 31, 2010
• Study Start: January 1, 2013
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-07