None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female paraplegics 18 years and older with spinal cord lesion, as a result of trauma, above L1 on a CIC program for bladder management and a score of ?A? on ASIA scale (Table 1.). 2. Male and female patients age 6 and older with myelomeningocele spina bifida 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
Exclusion criteria: 1. History of bladder cancer, augmentation, or radiation 2. Anatomic outlet obstruction or urethral strictures 3. Spina Bifida subjects who require a walker or crutches to ambulate 4. Spina Bifida subjects who do not ambulate 5. Contraindications to general anesthesia or surgery 6. Inability to complete follow up visits for 3 years 7. Inability to comprehend and answer self administered questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| by conducting pre and post procedure clinical exams, and completing voiding diariesTimepoint: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| validated questionnaires to assess changes in urinary, bowel, and sexual function, and functional status and quality of life.Timepoint: Not Applicable | — |
Countries
India
Contacts
Consultant