Urinary Incontinence Clinical Trial
Official title:
Lumbar to Sacral Ventral Nerve Re-Routing
Verified date | October 2015 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 13 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Kenneth Peters, MD | William Beaumont Hospitals |
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. — View 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. — View Citation
Müller 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. Review. — View 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. Epub 2005 Nov 2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients. | evaluated at 6 months and 1 year | No | |
Secondary | Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients | evaluated at 6 month and 1 year visit | No | |
Secondary | Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients | evaluate at 6 month and 1 year | No | |
Secondary | 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 | evaluate at 6 month and 1 year visit | No | |
Secondary | Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older | evaluate at 6 months and 1 year | No |
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