Neurogenic bladder
Conditions
Interventions
1:Nerve rerouting
Sponsors
C.G. Xiao Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male and female patients age 5 and older with neurogenic bladder voiding dysfunction secondary to radical hysterectomy, radical surgrey of rectum or sacral spine tumors, and on a CIC program for bladder management for at least one year prior to screening; 2.Atonic bladder documented by urodynamic testing during screening; 3.Documented history and no recurrence of the tumor; 4.Stable neurogenic bladder dysfunction of at least 1 year or more; 5.Normal renal function (cr normal); 6.Catheterized volume must be at least 50% of total bladder capacity.
Exclusion criteria
Exclusion criteria: 1.History of bladder augmentation, or radiation; 2.Anatomic outlet obstruction or urethral strictures; 3.History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT; 4.Subjects with an artificial bladder sphincter; 5.Subjects who have had a sling procedure; 6.Subjects who have had the mitrofanoff procedure; 7.Bladder botox injections within last 12 months; 8.Unable to ambulate independently with or without AFOs; 9.Subject is pregnant; 10.Contraindications to general anesthesia or surgery; 11.Inability to complete follow up visits for 1 years; 12.Inability to complete (or have parent complete) self administered questionnaires; 13.Subject possesses any other characteristics that, per investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Voluntary voiding; | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual urine; | — |
Countries
China
Contacts
Public ContactChuan-Guo Xiao
C.G. Xiao Hospital
Outcome results
None listed