NCT02948842

Clostridium Histolyticum Collagenase Injection for Urethral Disease

Completed Phase 2 Results posted Last updated 3 November 2023

What this trial tests

Phase 2 trial testing Clostridium Histolyticum Collagenase in Urethral Stricture in 5 participants. Completed in 12 April 2023.

Timeline

22 May 2020

Primary endpoint
4 March 2023

12 April 2023

Quick facts

Lead sponsor	University of South Florida
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	22 May 2020
Primary completion	4 March 2023
Estimated completion	12 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Clostridium Histolyticum Collagenase — full drug profile →
• Saline

Conditions studied

• Urethral Stricture — all drugs for Urethral Stricture →

Sponsor

University of South Florida

Who can join

18 and older, male only, with Urethral Stricture. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Complication After Treatment Primary · 84 days

Number of subjects with complication after treatment with clostridium histolyticum collagenase

Group	Value	95% CI
Treatment Group	0

Number of Patients Needing Further Intervention for Treatment of Urethral Stricture Secondary · 2 years

Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.

Group	Value	95% CI
Treatment Group	3

Number of Subjects With Recurrence of Urethral Stricture Secondary · 2 years

Number of subjects with recurrence of urethral stricture

Group	Value	95% CI
Treatment Group	0

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

Group	Value	95% CI
Treatment Group	-11.5	± 3.5

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

Group	Value	95% CI
Treatment Group	-2.5	± 14.8

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

Group	Value	95% CI
Treatment Group	-17

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

Group	Value	95% CI
Treatment Group	-19

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

Group	Value	95% CI
Treatment Group	-24

Time to Additional Intervention for Urethral Stricture Secondary · 2 years

Group	Value	95% CI
Treatment Group	6	1 – 18

Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow) Secondary · 6 weeks

Obstructive voiding dysfunction defined as change in uroflow

Group	Value	95% CI
Treatment Group	1.5	± 6.4

Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow) Secondary · 6 months

Obstructive voiding dysfunction defined as change in uroflow

Group	Value	95% CI
Treatment Group	-5.5	± 7.8

Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow) Secondary · 9 months

Obstructive voiding dysfunction defined as change in uroflow

Group	Value	95% CI
Treatment Group	3.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (5 terms — click to expand)

Reaction	System	Treatment Group
Dysuria	Renal and urinary disorders	—
Hematuria	Renal and urinary disorders	—
Worsening of urethral stricture	Renal and urinary disorders	—
Post void dribbling	Renal and urinary disorders	—
Right thigh pain	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT02948842 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.