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Completed

NCT Number: NCT02948842

Clostridium Histolyticum Collagenase Injection for Urethral Disease

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

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Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clostridium Histolyticum Collagenase

Drug

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 names: XIAFLEX®

Saline

Other

0.08ml of injectable normal saline

Other names: Injectable normal saline

Primary outcomes

  1. Number of Subjects With Complication After Treatment

    Time frame: 84 days

    Number of subjects with complication after treatment with clostridium histolyticum collagenase

Secondary outcomes

  1. Number 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. Number of Subjects With Recurrence of Urethral Stricture

    Time frame: 2 years

    Number of subjects with recurrence of urethral stricture

  3. Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores

    Time frame: 6 weeks

    The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.

  4. Change From Baseline and 6 Months: American Urology Association Questionnaire Scores

    Time frame: 6 months

    The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.

  5. Change From Baseline and 9 Months: American Urology Association Questionnaire Scores

    Time frame: 9 months

    The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.

  6. Change From Baseline and 12 Months: American Urology Association Questionnaire Scores

    Time frame: 12 months

    The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.

  7. Change From Baseline and 2 Years: American Urology Association Questionnaire Scores

    Time frame: 2 years

    The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.

  8. Time to Urethral Stricture Recurrence

    Time frame: 2 years

  9. Time to Additional Intervention for Urethral Stricture

    Time frame: 2 years

  10. Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow)

    Time frame: 6 weeks

    Obstructive voiding dysfunction defined as change in uroflow

  11. Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow)

    Time frame: 6 months

    Obstructive voiding dysfunction defined as change in uroflow

  12. Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow)

    Time frame: 9 months

    Obstructive voiding dysfunction defined as change in uroflow

  13. Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow)

    Time frame: 12 months

    Obstructive voiding dysfunction defined as change in uroflow

  14. Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow)

    Time frame: 18 months

    Obstructive voiding dysfunction defined as change in uroflow

  15. Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow)

    Time frame: 2 years

    Obstructive voiding dysfunction defined as change in uroflow

  16. Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements)

    Time frame: 6 weeks

    Obstructive voiding dysfunction defined as change in post-void residual measurements

  17. Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)

    Time frame: 6 months

    Obstructive voiding dysfunction defined as change in post-void residual measurements

  18. Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)

    Time frame: 9 months

    Obstructive voiding dysfunction defined as change in post-void residual measurements

  19. Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)

    Time frame: 12 months

    Obstructive voiding dysfunction defined as change in post-void residual measurements

  20. Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)

    Time frame: 18 months

    Obstructive voiding dysfunction defined as change in post-void residual measurements

  21. Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements)

    Time frame: 2 years

    Obstructive voiding dysfunction defined as change in post-void residual measurements

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2016
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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