5
Participants
Start Date
May 22, 2020
Primary Completion Date
March 4, 2023
Study Completion Date
April 12, 2023
Clostridium Histolyticum Collagenase
0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring.
Saline
0.08ml of injectable normal saline
University of South Florida - South Tampa Campus, Tampa
University of South Florida
OTHER