Clostridium Histolyticum Collagenase Injection for Urethral Disease

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Treatments: Lidocaine

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 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