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Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

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ClinicalTrials.gov Identifier: NCT00918528
Recruitment Status : Unknown
Verified June 2009 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2009
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
Hillel Yaffe Medical Center

Brief Summary:
The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.

Condition or disease Intervention/treatment Phase
Urethral Stricture Procedure: Internal urethrotomy Drug: Mitomycin C - local injection Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Mitomycin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1. Internal urethrotomy Procedure: Internal urethrotomy
Experimental: 2. Internal urethrotomy + mitomycin C Procedure: Internal urethrotomy Drug: Mitomycin C - local injection



Primary Outcome Measures :
  1. Urethral stricture recurrence [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male urethral stricture suitable for internal urethrotomy
  • Stricture length less than 10 mm

Exclusion Criteria:

  • Stricture length over 10 mm
  • Benign prostate enlargement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918528


Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Michael Mullerad, MD    972-4-630-4440      
Contact: Nachum Erlich, MD    972-4-630-4440    erlichn@hy.health.gov.il   
Principal Investigator: Michael Mullerad, MD         
Principal Investigator: Nachum Erlich, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Nachum Erlich, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00918528     History of Changes
Other Study ID Numbers: 0020-09-HYMC
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by Hillel Yaffe Medical Center:
Urethral stricture
Mitomycin C
Internal Urethrotomy

Additional relevant MeSH terms:
Constriction, Pathologic
Urethral Stricture
Pathological Conditions, Anatomical
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors