Augmentation Cystoplasty Using an Autologous Neo-Bladder
Subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida|
- Number of Responders as Assessed by Compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders
- Overall Safety Profile - Number of Participants Experiencing an Adverse Event [ Time Frame: periodically within first 12 months as well as during long term follow up out to 5 years ] [ Designated as safety issue: Yes ]clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.
|Study Start Date:||December 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Receipt of autologous neo-bladder construct
Other: Autologous neo bladder construct
augmentation cystoplasty with autologous neo-bladder construct