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Clostridium Histolyticum Collagenase Injection for Urethral Disease

Primary Purpose

Urethral Stricture

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clostridium Histolyticum Collagenase
Saline
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 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

Sites / Locations

  • University of South Florida - South Tampa CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm 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.

Outcomes

Primary Outcome Measures

Incidence of complication after treatment
Rate of complication after treatment with clostridium histolyticum collagenase and saline

Secondary Outcome Measures

Proportion of patients needing further intervention for treatment of urethral stricture
Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.
Incidence of recurrence of urethral stricture
Change from baseline over time during total study period on: American Urology Association questionnaire scores
Time to urethral stricture recurrence
Time to additional intervention for urethral stricture
Change from baseline over time during total study period on: obstructive voiding dysfunction
Obstructive voiding dysfunction defined as change in uroflow and post-void residual measurements

Full Information

First Posted
October 26, 2016
Last Updated
August 24, 2022
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02948842
Brief Title
Clostridium Histolyticum Collagenase Injection for Urethral Disease
Official Title
Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Clostridium Histolyticum Collagenase
Other Intervention Name(s)
XIAFLEX®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Injectable normal saline
Intervention Description
0.08ml of injectable normal saline
Primary Outcome Measure Information:
Title
Incidence of complication after treatment
Description
Rate of complication after treatment with clostridium histolyticum collagenase and saline
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Proportion of patients needing further intervention for treatment of urethral stricture
Description
Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.
Time Frame
2 years
Title
Incidence of recurrence of urethral stricture
Time Frame
2 years
Title
Change from baseline over time during total study period on: American Urology Association questionnaire scores
Time Frame
2 years
Title
Time to urethral stricture recurrence
Time Frame
2 years
Title
Time to additional intervention for urethral stricture
Time Frame
2 years
Title
Change from baseline over time during total study period on: obstructive voiding dysfunction
Description
Obstructive voiding dysfunction defined as change in uroflow and post-void residual measurements
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique Perry, MHA
Phone
813-844-5972
Email
vperry@tgh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ray de la Morena Quirch, PhD
Phone
83-844-8824
Email
rdelamorena@tgh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas R Wiegand, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida - South Tampa Campus
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray de la Morena Quirch, MPH
Phone
813-844-8824
Email
rdelamorena@tgh.org
First Name & Middle Initial & Last Name & Degree
Lucas Wiegand, MD
First Name & Middle Initial & Last Name & Degree
Kevin Heinsimer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17437780
Citation
Santucci RA, Joyce GF, Wise M. Male urethral stricture disease. J Urol. 2007 May;177(5):1667-74. doi: 10.1016/j.juro.2007.01.041.
Results Reference
result
PubMed Identifier
21315996
Citation
Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
Results Reference
result
PubMed Identifier
9679876
Citation
Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5.
Results Reference
result
PubMed Identifier
15541123
Citation
Hussain M, Greenwell TJ, Shah J, Mundy A. Long-term results of a self-expanding wallstent in the treatment of urethral stricture. BJU Int. 2004 Nov;94(7):1037-9. doi: 10.1111/j.1464-410X.2004.05100.x.
Results Reference
result
PubMed Identifier
24745607
Citation
Zhang K, Qi E, Zhang Y, Sa Y, Fu Q. Efficacy and safety of local steroids for urethra strictures: a systematic review and meta-analysis. J Endourol. 2014 Aug;28(8):962-8. doi: 10.1089/end.2014.0090. Epub 2014 Jun 3.
Results Reference
result
PubMed Identifier
26491251
Citation
Peak TC, Mitchell GC, Yafi FA, Hellstrom WJ. Role of collagenase clostridium histolyticum in Peyronie's disease. Biologics. 2015 Sep 29;9:107-16. doi: 10.2147/BTT.S65619. eCollection 2015.
Results Reference
result
PubMed Identifier
23376148
Citation
Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.
Results Reference
result
PubMed Identifier
17617144
Citation
Cavalcanti AG, Costa WS, Baskin LS, McAninch JA, Sampaio FJ. A morphometric analysis of bulbar urethral strictures. BJU Int. 2007 Aug;100(2):397-402. doi: 10.1111/j.1464-410X.2007.06904.x.
Results Reference
result
PubMed Identifier
26126692
Citation
Sangkum P, Yafi FA, Kim H, Bouljihad M, Ranjan M, Datta A, Mandava SH, Sikka SC, Abdel-Mageed AB, Moparty K, Hellstrom WJ. Collagenase Clostridium histolyticum (Xiaflex) for the Treatment of Urethral Stricture Disease in a Rat Model of Urethral Fibrosis. Urology. 2015 Sep;86(3):647.e1-6. doi: 10.1016/j.urology.2015.06.013. Epub 2015 Jun 27.
Results Reference
result
Links:
URL
http://www.endo.com/File%20Library/Products/Prescribing%20Information/Xiaflex_prescribing_information.html
Description
XIAFLEX® [package insert]

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Clostridium Histolyticum Collagenase Injection for Urethral Disease

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