Clostridium Histolyticum Collagenase Injection for Urethral Disease

University of South Florida5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urethral Stricture

Interventions

Clostridium Histolyticum CollagenaseDRUG

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.

SalineOTHER

0.08ml of injectable normal saline

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of South Florida - South Tampa Campus

Tampa, Florida, United States

Outcomes

Primary Outcomes

Number of Subjects With Complication After Treatment

Number of subjects with complication after treatment with clostridium histolyticum collagenase

Time frame: 84 days

Secondary Outcomes

Number of Patients Needing Further Intervention for Treatment of Urethral Stricture

Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.

Time frame: 2 years

Number of Subjects With Recurrence of Urethral Stricture

Number of subjects with recurrence of urethral stricture

Time frame: 2 years

Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores

The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.

Time frame: 6 weeks

Change From Baseline and 6 Months: American Urology Association Questionnaire Scores

Time frame: 6 months

Change From Baseline and 9 Months: American Urology Association Questionnaire Scores

Data from ClinicalTrials.gov

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