Trial · NCT02948842
Clostridium Histolyticum Collagenase Injection for Urethral Disease
NCT02948842, Phase 2, Completed, University of South Florida; results first posted 2023-11-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clostridium Histolyticum Collagenase Injection for Urethral Disease. Trials, record NCT02948842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02948842
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clostridium Histolyticum Collagenase Injection for Urethral Disease
- NCT number
- NCT02948842
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- University of South Florida
- Conditions
- Urethral Stricture
- Interventions
- Clostridium Histolyticum Collagenase, Saline
- First posted
- 2016-10-28
- Last updated
- 2023-11-03
- Results first posted
- 2023-11-03
- Limitations and caveats
These are first-in-human cases with collagenase clostridium histolyticum (CCH) treatment for urethral stricture, although number of treated patients is low. Future directions will hopefully include increased sample size through multi-institutional participation and adjunctive procedures designed to augment the proposed beneficial effects of CCH therapy.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Complication After Treatment | 84 days | Number of subjects with complication after treatment with clostridium histolyticum collagenase |
| Secondary | Number 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. |
| Secondary | Number of Subjects With Recurrence of Urethral Stricture | 2 years | Number of subjects with recurrence of urethral stricture |
| Secondary | Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores | 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. |
| Secondary | Change From Baseline and 6 Months: American Urology Association Questionnaire Scores | 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. |
| Secondary | Change From Baseline and 9 Months: American Urology Association Questionnaire Scores | 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. |
| Secondary | Change From Baseline and 12 Months: American Urology Association Questionnaire Scores | 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. |
| Secondary | Change From Baseline and 2 Years: American Urology Association Questionnaire Scores | 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. |
| Secondary | Time to Urethral Stricture Recurrence | 2 years | |
| Secondary | Time to Additional Intervention for Urethral Stricture | 2 years |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Complication After Treatment | 84 days | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Needing Further Intervention for Treatment of Urethral Stricture | 2 years | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Recurrence of Urethral Stricture | 2 years | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores | 6 weeks | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 weeks follow-up. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline and 6 Months: American Urology Association Questionnaire Scores | 6 months | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 months follow-up. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline and 9 Months: American Urology Association Questionnaire Scores | 9 months | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 9 months follow-up. | scores on a scale | NUMBER |
| SECONDARY | Change From Baseline and 12 Months: American Urology Association Questionnaire Scores | 12 months | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 12 months follow-up. | scores on a scale | NUMBER |
| SECONDARY | Change From Baseline and 2 Years: American Urology Association Questionnaire Scores | 2 years | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 2 years follow-up. | scores on a scale | NUMBER |
| SECONDARY | Time to Urethral Stricture Recurrence | 2 years | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. None of the treated subjects had recurrence of urethral stricture. | ||
| SECONDARY | Time to Additional Intervention for Urethral Stricture | 2 years | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | months | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Complication After Treatment | Treatment Group | 0 | Participants | ||
| Number of Patients Needing Further Intervention for Treatment of Urethral Stricture | Treatment Group | 3 | Participants | ||
| Number of Subjects With Recurrence of Urethral Stricture | Treatment Group | 0 | Participants | ||
| Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores | Treatment Group | -11.5 | Standard Deviation 3.5 | scores on a scale | |
| Change From Baseline and 6 Months: American Urology Association Questionnaire Scores | Treatment Group | -2.5 | Standard Deviation 14.8 | scores on a scale | |
| Change From Baseline and 9 Months: American Urology Association Questionnaire Scores | Treatment Group | -17 | scores on a scale | ||
| Change From Baseline and 12 Months: American Urology Association Questionnaire Scores | Treatment Group | -19 | scores on a scale | ||
| Change From Baseline and 2 Years: American Urology Association Questionnaire Scores | Treatment Group | -24 | scores on a scale | ||
| Time to Additional Intervention for Urethral Stricture | Treatment Group | 6 | Full Range 1 to 18 | months | |
| Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow) | Treatment Group | 1.5 | Standard Deviation 6.4 | mL/s |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group | 5 | |
| Overall Study | COMPLETED | Treatment Group | 1 | |
| Overall Study | NOT COMPLETED | Treatment Group | 4 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dysuria | Renal and urinary disorders | Treatment Group | 2 | 3 | |
| other | Hematuria | Renal and urinary disorders | Treatment Group | 2 | 3 | |
| other | Worsening of urethral stricture | Renal and urinary disorders | Treatment Group | 2 | 3 | |
| other | Post void dribbling | Renal and urinary disorders | Treatment Group | 1 | 3 | |
| other | Right thigh pain | Renal and urinary disorders | Treatment Group | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | 0 | 3 |
| Total, other adverse events | Treatment Group | 2 | 3 |
| Total, serious adverse events | Treatment Group | 0 | 3 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02948842
GET https://conductscience.org/api/trials/v1/NCT02948842/registered?page=2