Phase 2
Completed N=5
Clostridium Histolyticum Collagenase Injection for Urethral Disease
Source: ClinicalTrials.gov NCT02948842 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Subjects With Complication After Treatment — 0 Participants
Summary
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Complication After Treatment |
— | — |
| SECONDARY Number of Patients Needing Further Intervention for Treatment of Urethral Stricture |
3 | — |
| SECONDARY Number of Subjects With Recurrence of Urethral Stricture |
— | — |
| SECONDARY Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores |
-11.5 | — |
| SECONDARY Change From Baseline and 6 Months: American Urology Association Questionnaire Scores |
-2.5 | — |
| SECONDARY Change From Baseline and 9 Months: American Urology Association Questionnaire Scores |
-17 | — |
| SECONDARY Change From Baseline and 12 Months: American Urology Association Questionnaire Scores |
-19 | — |
| SECONDARY Change From Baseline and 2 Years: American Urology Association Questionnaire Scores |
-24 | — |
| SECONDARY Time to Urethral Stricture Recurrence |
— | — |
| SECONDARY Time to Additional Intervention for Urethral Stricture |
6 | — |
| SECONDARY Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow) |
1.5 | — |
| SECONDARY Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow) |
-5.5 | — |
| SECONDARY Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow) |
3.6 | — |
| SECONDARY Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow) |
5.8 | — |
| SECONDARY Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow) |
19 | — |
| SECONDARY Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow) |
9.2 | — |
| SECONDARY Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements) |
-41.5 | — |
| SECONDARY Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) |
175.5 | — |
| SECONDARY Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) |
125 | — |
| SECONDARY Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) |
46 | — |
| SECONDARY Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) |
-48 | — |
| SECONDARY Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements) |
-15 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02948842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.