Clostridium Histolyticum Collagenase Injection for Urethral Disease

University of South Florida

Status and phase: Completed; Phase 2

Conditions: Urethral Stricture

Treatments: Drug: Clostridium Histolyticum Collagenase; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02948842

CHC

Details and patient eligibility

About

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

Full description

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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Treatment Group

Experimental group

Description:

Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 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.

Treatment:

Other: Saline

Drug: Clostridium Histolyticum Collagenase