Clostridium Histolyticum Collagenase Injection for Urethral Disease
Clostridium Histolyticum Collagenase Injection for Urethral Disease
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase
 (XIAFLEX®) in treating urethral strictures.
This is an open-label, pilot study to explore the efficacy of clostridium histolyticum
 collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years
 from the initial drug treatment.
Inclusion Criteria:

 -  Males

 -  Age ≥ 18 years

 -  Failed prior proven conservative measures, including DVIU or balloon dilation of the
 stricture will be included in this study

 -  Able and willing to undergo regular intervention as well as evaluation as described
 below will be included in the study

 -  With a single stricture <2cm in size that can be identified on retrograde urethrogram
 or voiding cystourethrogram will be included in the study.

 -  Must agree not to participate in a clinical study involving another investigational
 drug or device throughout the duration of this study

 -  Must be competent to understand the information given in IRB approved ICF and must
 sign the form prior to the initiation of any study procedure

 Exclusion Criteria:

 -  Has not yet undergone proven non-invasive measures, including DVIU or balloon
 dilation.

 -  Multiple strictures or a single stricture larger than 2cm in size, measured with
 retrograde urethrogram or voiding cystourethrogram.

 -  Age <18

 -  Females

 -  Prior urethroplasty

 -  Urethral fistula

 -  Allergy or sensitivity to CHC

 -  Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day

 -  Untreated urinary tract infection

 -  Inability to perform intermittent self-catheterization

 -  Participation in another clinical study or treatment with an investigational drug or
 device

 -  Serious or active medical or psychiatric condition which, in the opinion of the
 Investigator, may interfere with treatment, assessment, or compliance with the
 protocol