Clostridium Histolyticum Collagenase Injection for Urethral Disease
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
|
| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of complication after treatment [84 days]
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 [2 years]
Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.
- Incidence of recurrence of urethral stricture [2 years]
- Change from baseline over time during total study period on: American Urology Association questionnaire scores [2 years]
- Time to urethral stricture recurrence [2 years]
- Time to additional intervention for urethral stricture [2 years]
- Change from baseline over time during total study period on: obstructive voiding dysfunction [2 years]
Obstructive voiding dysfunction defined as change in uroflow and post-void residual measurements
Eligibility Criteria
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
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Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study
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With a single stricture <2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study.
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Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study
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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.
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Age <18
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Females
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Prior urethroplasty
-
Urethral fistula
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Allergy or sensitivity to CHC
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Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day
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Untreated urinary tract infection
-
Inability to perform intermittent self-catheterization
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Florida - South Tampa Campus | Tampa | Florida | United States | 33606 |
Sponsors and Collaborators
- University of South Florida
Investigators
- Principal Investigator: Lucas R Wiegand, MD, University of South Florida
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CHC