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Lumbar to Sacral Ventral Nerve Re-Routing

Primary Purpose

Urinary Incontinence, Spinal Cord Injury, Spina Bifida

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
lumbar to sacral ventral nerve re-routing procedure
Sponsored by
Kenneth Peters, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, spinal cord injury, spina bifida

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.

    Outcomes

    Primary Outcome Measures

    Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.

    Secondary Outcome Measures

    Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients
    Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients
    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
    Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older

    Full Information

    First Posted
    September 19, 2006
    Last Updated
    October 13, 2015
    Sponsor
    Kenneth Peters, MD
    Collaborators
    William Beaumont Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00378664
    Brief Title
    Lumbar to Sacral Ventral Nerve Re-Routing
    Official Title
    Lumbar to Sacral Ventral Nerve Re-Routing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kenneth Peters, MD
    Collaborators
    William Beaumont Hospitals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence, Spinal Cord Injury, Spina Bifida
    Keywords
    urinary incontinence, spinal cord injury, spina bifida

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    lumbar to sacral ventral nerve re-routing procedure
    Intervention Description
    surgical nerve re-routing procedure
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth M Peters, M.D.
    Organizational Affiliation
    William Beaumont Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16314037
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16029629
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12353510
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12409876
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24987412
    Citation
    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.
    Results Reference
    derived

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    Lumbar to Sacral Ventral Nerve Re-Routing

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