Clostridium Histolyticum Collagenase Injection for Urethral Disease

Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study

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, 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