Status:
COMPLETED
Lumbar to Sacral Ventral Nerve Re-Routing
Lead Sponsor:
Kenneth Peters, MD
Collaborating Sponsors:
Corewell Health East
Conditions:
Urinary Incontinence
Spinal Cord Injury
Eligibility:
All Genders
6+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00378664
Start Date
September 1 2006
End Date
January 1 2015
Last Update
October 14 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.