Clostridium Histolyticum Collagenase Injection for Urethral Disease

  • STATUS
    Recruiting
  • End date
    Jun 23, 2024
  • participants needed
    5
  • sponsor
    University of South Florida
Updated on 7 October 2022

Summary

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

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.

Details
Condition Urethral Stricture
Treatment Saline, Clostridium Histolyticum Collagenase, Clostridium Histolyticum Collagenase
Clinical Study IdentifierNCT02948842
SponsorUniversity of South Florida
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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