Clostridium Histolyticum Collagenase Injection for Urethral Disease
NCT ID: NCT02948842
Last Updated: 2023-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
5 participants
INTERVENTIONAL
2020-05-22
2023-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Saline
0.08ml of injectable normal saline
Interventions
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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.
Saline
0.08ml of injectable normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \<2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study.
* Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study
* 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
* Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram, voiding cystourethrogram, or urethral ultrasonography.
* Corporal spongiosum tissues \< 5 mm in depth at proposed injection site
* Grade 5 spongiofibrosis
* Age \<18
* Females
* Prior urethroplasty
* Urethral fistula
* History of penile cancer, prostate cancer, or urinary tract malignancy (bladder, urethral, ureteral, or kidney).
* History of radiation (external or brachytherapy) to the pelvic organs, penis or groin.
* History of autoimmune or inflammatory bowel disease
* Contraindication to suprapubic tube placement
* Pre-procedure PVR \>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
18 Years
MALE
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Lucas R Wiegand, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida - South Tampa Campus
Tampa, Florida, United States
Countries
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References
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Santucci RA, Joyce GF, Wise M. Male urethral stricture disease. J Urol. 2007 May;177(5):1667-74. doi: 10.1016/j.juro.2007.01.041.
Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5.
Hussain M, Greenwell TJ, Shah J, Mundy A. Long-term results of a self-expanding wallstent in the treatment of urethral stricture. BJU Int. 2004 Nov;94(7):1037-9. doi: 10.1111/j.1464-410X.2004.05100.x.
Zhang K, Qi E, Zhang Y, Sa Y, Fu Q. Efficacy and safety of local steroids for urethra strictures: a systematic review and meta-analysis. J Endourol. 2014 Aug;28(8):962-8. doi: 10.1089/end.2014.0090. Epub 2014 Jun 3.
Peak TC, Mitchell GC, Yafi FA, Hellstrom WJ. Role of collagenase clostridium histolyticum in Peyronie's disease. Biologics. 2015 Sep 29;9:107-16. doi: 10.2147/BTT.S65619. eCollection 2015.
Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.
Cavalcanti AG, Costa WS, Baskin LS, McAninch JA, Sampaio FJ. A morphometric analysis of bulbar urethral strictures. BJU Int. 2007 Aug;100(2):397-402. doi: 10.1111/j.1464-410X.2007.06904.x.
Sangkum P, Yafi FA, Kim H, Bouljihad M, Ranjan M, Datta A, Mandava SH, Sikka SC, Abdel-Mageed AB, Moparty K, Hellstrom WJ. Collagenase Clostridium histolyticum (Xiaflex) for the Treatment of Urethral Stricture Disease in a Rat Model of Urethral Fibrosis. Urology. 2015 Sep;86(3):647.e1-6. doi: 10.1016/j.urology.2015.06.013. Epub 2015 Jun 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CHC
Identifier Type: -
Identifier Source: org_study_id
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