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Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida

Primary Purpose

Spina Bifida

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nerve Rerouting
Sponsored by
Kenneth Peters, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spina Bifida focused on measuring spina, bifida, restore, urinary, function, nerve, reroute

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2010
    Last Updated
    July 31, 2013
    Sponsor
    Kenneth Peters, MD
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01096459
    Brief Title
    Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida
    Official Title
    Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Protocol as presented by investigator was not approved by the NIDDK.
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kenneth Peters, MD
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spina Bifida
    Keywords
    spina, bifida, restore, urinary, function, nerve, reroute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Nerve Rerouting
    Intervention Description
    All subjects will receive the unilateral nerve rerouting procedure.
    Primary Outcome Measure Information:
    Title
    Reproducible bladder contraction
    Description
    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.
    Time Frame
    6 to 24 months post procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 Subject possesses any other characteristics that, per investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth Peters, MD
    Organizational Affiliation
    William Beaumont Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida

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