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发表于 2012-3-4 12:39
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美国健康总署2011年8月更新的公告
征集”肖式反射弧“实验志愿者的公告
征集人数：16；实验期起自2011年12月
终止日期：2015年4月；前期实验止于：2013年4月
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Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida
This study is not yet open for participant recruitment.
Verified August 2011 by William Beaumont Hospitals
First Received on March 23, 2010. Last Updated on August 19, 2011 History of Changes
Sponsor: William Beaumont Hospitals
Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party): William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01096459
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:
Genetics Home Reference related topics: spina bifida
MedlinePlus related topics: Spina Bifida
U.S. FDA Resources
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.
Secondary Outcome Measures:
Transfer of knowledge to other personnel to learn the procedure [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Transfer of knowledge will be measured by comparing the following primary and secondary outcome measures across centers.
Global response assessment for voiding, defecation, and QOL
Percent voided/percent catheterized
Presence of detrusor sphincter dysynergia
Presence of urge incontinence
Presence of stress incontinence
Change in incontinence severity quantified by pad weights
Need for intermittent catheterization
Change in anal manometry
Change in bowel function
Change in quality of life
Goal Achievement
Adverse events
Estimated Enrollment: 16
Study Start Date: December 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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 Chinise 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:
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096459
Locations
United States, Michigan
William Beaumont Hospital Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kim Killinger, RN 248-551-3565
Principal Investigator: Kenneth Peters, MD
Sponsors and Collaborators
William Beaumont Hospitals
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
More Information
No publications provided
Responsible Party: 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: August 19, 2011
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 March 01, 2012
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Links to all studies - primarily for crawlers
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发表于 2012-3-4 00:37
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发表于 2012-3-4 08:55
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