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Clostridium Histolyticum Collagenase Injection for Urethral Disease

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ClinicalTrials.gov Identifier: NCT02948842
Recruitment Status : Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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

Condition or disease Intervention/treatment Phase
Urethral Stricture Drug: Clostridium Histolyticum Collagenase Other: Saline Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
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.
Drug: 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.
Other Name: XIAFLEX®

Placebo Comparator: Control Group
On day of treatment, 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 injectable normal saline. The depth and location of the needle will be determined pre-procedurally with urethral ultrasonography with the needle in a semi-parallel manner into the plaque as to avoid perforation into nearby structures. Injections will be performed at a single site.
Other: Saline
0.08ml of injectable normal saline
Other Name: Injectable normal saline




Primary Outcome Measures :
  1. Incidence of complication after treatment [ Time Frame: 84 days ]
    Rate of complication after treatment with clostridium histolyticum collagenase and saline


Secondary Outcome Measures :
  1. Proportion of patients needing further intervention for treatment of urethral stricture [ Time Frame: 2 years ]
    Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.

  2. Incidence of recurrence of urethral stricture [ Time Frame: 2 years ]
  3. Change from baseline over time during total study period on: American Urology Association questionnaire scores [ Time Frame: 2 years ]
  4. Time to urethral stricture recurrence [ Time Frame: 2 years ]
  5. Time to additional intervention for urethral stricture [ Time Frame: 2 years ]
  6. Change from baseline over time during total study period on: obstructive voiding dysfunction [ Time Frame: 2 years ]
    Obstructive voiding dysfunction defined as change in uroflow and post-void residual measurements



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948842


Contacts
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Contact: Thanh Tran, BS 813-844-8544 thanhtran@health.usf.edu
Contact: Rachel Karlnoski, PhD 83-844-4133 rkarlnos@health.usf.edu

Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Lucas R Wiegand, MD University of South Florida
Additional Information:
Publications of Results:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02948842    
Other Study ID Numbers: CHC
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urethral Stricture
Urethral Diseases
Urethral Obstruction
Urologic Diseases