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Enzyme

Clostridium Histolyticum Collagenase for Urethral Stricture

Phase 2

Waitlist Available

Led By Lucas R Wiegand, MD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether XIAFLEX can effectively treat urethral strictures, a common problem that can cause urinary difficulty.

Eligible Conditions

Urethral Stricture

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Subjects With Complication After Treatment

Secondary outcome measures

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

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

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

+18 more

Side effects data

From 2023 Phase 2 trial • 5 Patients • NCT02948842

67%

Hematuria

67%

Dysuria

67%

Worsening of urethral stricture

33%

Post void dribbling

33%

Right thigh pain

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Group

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clostridium Histolyticum Collagenase

2020

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor

407 Previous Clinical Trials

186,804 Total Patients Enrolled

Lucas R Wiegand, MDPrincipal InvestigatorUniversity of South Florida

Media Library

Clostridium Histolyticum Collagenase (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT02948842 — Phase 2

Urethral Stricture Research Study Groups: Treatment Group

Urethral Stricture Clinical Trial 2023: Clostridium Histolyticum Collagenase Highlights & Side Effects. Trial Name: NCT02948842 — Phase 2

Clostridium Histolyticum Collagenase (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02948842 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experiments that have explored the use of Clostridium Histolyticum Collagenase?

"Currently, 6 clinical trials are underway investigating Clostridium Histolyticum Collagenase. One of these studies has already progressed to the final phase and is based in Orem, Utah. Additionally, 11 medical centres across the world have initiated trials on this medication."

Answered by AI

How many participants are presently recruited to this research?

"Affirmative. According to clinicaltrials.gov, this medical study is actively seeking participants who fit its criteria. Initially posted in May 2020 and last updated in August 2022, it seeks 5 patients at 1 site for enrollment."

Answered by AI

What conditions is Clostridium Histolyticum Collagenase typically utilized to treat?

"Clostridium Histolyticum Collagenase is typically employed to address palpable cord, though it also has the potential to improve skin ulcers, 30 degree angle penile deformities, and Peyronie's disease."

Answered by AI

To what degree can Clostridium Histolyticum Collagenase be potentially hazardous?

"Given the Phase 2 nature of this trial, meaning while safety has been demonstrated there is no data in regards to efficacy, Clostridium Histolyticum Collagenase received a score of 2."

Answered by AI

Are there currently opportunities to join this research program?

"Affirmative. The information on clinicaltrials.gov corroborates that this trial is presently recruiting individuals for participation. This study was initialled posted on May 22nd 2020 and latest updated August 24th 2022, with a total of 5 participants sought from one medical facility."

Answered by AI

Recent research and studies

Journal of EndourologyJournal

Efficacy and Safety of Local Steroids for Urethra Strictures: A Systematic Review and Meta-analysis

Zhang, Kaile, Er Qi, Yumeng Zhang, Yinglong Sa, and Qiang Fu. 2014. “Efficacy and Safety of Local Steroids for Urethra Strictures: A Systematic Review and Meta-analysis”. Journal of Endourology. Mary Ann Liebert Inc. doi:10.1089/end.2014.0090.

Biologics: Targets and TherapyJournal

Role of Collagenase Clostridium Histolyticum in Peyronie's Disease

Hellstrom, Wayne, Taylor Peak, Gregory Mitchell, and Faysal Yafi. 2015. “Role of Collagenase Clostridium Histolyticum in Peyronie's Disease”. Biologics: Targets and Therapy. Informa UK Limited. doi:10.2147/btt.s65619.

Journal of UrologyJournal

Male Urethral Stricture Disease

Santucci, Richard A., Geoffrey F. Joyce, and Matthew Wise. 2007. “Male Urethral Stricture Disease”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2007.01.041.

BJU InternationalJournal