Trial record 7 of 45 for:    Spina Bifida

Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida

This study has been withdrawn prior to enrollment.
(Protocol as presented by investigator was not approved by the NIDDK.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01096459
First received: March 23, 2010
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Spina Bifida
Procedure: Nerve Rerouting

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Reproducible bladder contraction [ Time Frame: 6 to 24 months post procedure ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: January 2013
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Nerve Rerouting
    All subjects will receive the unilateral nerve rerouting procedure.
Detailed Description:

Spina Bifida (a congenital defect of the spinal cord), causes nerve damage and a loss of sensation and muscle function below the waist resulting in bowel and bladder dysfunction. Patients cannot urinate or are constantly wet, and this continues throughout life causing major quality of life and health problems. Clean intermittent catheterization (draining urine from the bladder with a tube) is usually needed to empty the bladder properly. Medications are routinely required to alleviate high urinary tract pressures that can cause irreversible kidney damage, where dialysis or kidney transplant is the only way to sustain life.

A Chinese urologist developed a novel procedure to connect a functioning, healthy lumbar spinal nerve to the sacral nerve that controls the bladder. Hundreds of these procedures have been done in China. The end result is the creation of a new reflex where the bladder can be emptied by scratching or stimulating the skin (over the hip or thigh) supplied by that spinal nerve root. The Chinese physician had reported that of 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, the reported success was 87% at one year. However, in China rigorous follow up is challenging, therefore much is still unknown about how the nerves regenerate post surgery, complications and results occurring in the first year in particular, and the potential role that central nervous system remodeling may play in achieving successful outcomes. Beaumont urologists were the first in the US to perform this surgery on children with spina bifida. Our preliminary data are very promising, and in 9 subjects at 12 months post procedure, 7/9 subjects could void either voluntarily or by stimulating the new reflex mechanism.

This current project aims to expand upon our pilot experience to conduct a larger and more rigorous study to establish the safety and effectiveness of the proposed somatic-autonomic reflex pathway procedure in gaining bladder and bowel control in patients with spina bifida. We will also collaborate with and train investigators at another site(s) to determine the training needed to achieve similar safety and effectiveness outcomes, and evaluate possible methods to stimulate the new reflex to improve bladder emptying. Achieving the aims outlined in this multicenter proposal will help firmly establish the procedure as safe and effective, and revolutionize the treatment of bladder and bowel dysfunction in patients with spina bifida in the US.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Atonic or hyperreflexic bladder documented by urodynamic testing during screening. .
  3. Documented history of no more than one tethered cord surgery/release in the past; must be > 2 years post tethered cord surgery/release
  4. Stable neurogenic bladder dysfunction of at least 1 year or more
  5. Normal renal function (cr<1.5 mg/dl or GFR >75)
  6. Ambulate independently with or without ankle-foot orthotics (AFOs).
  7. Catheterized volume must be at least 50% of total bladder capacity.

Exclusion Criteria:

  1. History of bladder cancer, augmentation, or radiation
  2. Anatomic outlet obstruction or urethral strictures
  3. History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT
  4. Hydronephrosis grade 3 or higher
  5. Presence of an ileal conduit or supra-pubic catheter drainage
  6. Subjects with an artificial bladder sphincter
  7. Subjects who have had a sling procedure
  8. Subjects who have had the mitrofanoff procedure
  9. Bladder botox injections within last 12 months
  10. Spina Bifida subjects who underwent intrauterine closure of their myelomeningocele
  11. Unable to ambulate independently with or without AFOs.
  12. Subject is pregnant
  13. Contraindications to general anesthesia or surgery
  14. Inability to complete follow up visits for 2 years
  15. Inability to complete (or have parent complete) self administered questionnaires
  16. Subject possesses any other characteristics that, per investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096459

Sponsors and Collaborators
Kenneth Peters, MD
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01096459     History of Changes
Other Study ID Numbers: 2010-029, RO1DK084034
Study First Received: March 23, 2010
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
spina
bifida
restore
urinary
function
nerve
reroute

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Spinal Dysraphism
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 22, 2014