Clostridium Histolyticum Collagenase Injection for Urethral Disease
Condition: Urethral Stricture
MeSH terms: Urethral Stricture; Urethral Diseases
Intervention: Clostridium Histolyticum Collagenase; Saline
Intervention description: 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.; 0.08ml of injectable normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase
      (XIAFLEX®) in treating urethral strictures.
    

Eligibility criteria:

        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, voiding cystourethrogram, or urethral ultrasonography.

          -  Corporal spongiosum tissues < 5 mm in depth at proposed injection site

          -  Grade 5 spongiofibrosis

          -  Age <18

          -  Females

          -  Prior urethroplasty

          -  Urethral fistula

          -  History of penile cancer, prostate cancer, or urinary tract malignancy (bladder,
             urethral, ureteral, or kidney).

          -  History of radiation (external or brachytherapy) to the pelvic organs, penis or groin.

          -  History of autoimmune or inflammatory bowel disease

          -  Contraindication to suprapubic tube placement

          -  Pre-procedure PVR >250mL

          -  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