Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
augmentation cystoplasty with autologous neo-bladder construct
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Change in Maximum Detrusor Pressure From Baseline to 12 Months
Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.
Time frame: baseline and 12 months
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
Clinical evaluation of adverse events experienced by patients enrolled in the trial.
Time frame: through month 12
Urodynamic Measurements and Long Term Safety
Safety results are summarized in the Adverse Events section of this listing.
Time frame: month 12 through month 60
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