Clinical trial
Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study
Name
CHC
Description
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
Trial arms
Trial start
2020-05-22
Estimated PCD
2023-03-04
Trial end
2023-04-12
Status
Completed
Phase
Early phase I
Treatment
Clostridium Histolyticum Collagenase
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.
Arms:
Treatment Group
Other names:
XIAFLEX®
Saline
0.08ml of injectable normal saline
Arms:
Treatment Group
Other names:
Injectable normal saline
Size
5
Primary endpoint
Number of Subjects With Complication After Treatment
84 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2023-11-03
1 organization
1 product
1 indication
Organization
University of South FloridaIndication
Urethral Stricture