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Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918528
First Posted: June 11, 2009
Last Update Posted: June 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hillel Yaffe Medical Center
  Purpose
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 Intervention Phase
Urethral Stricture Procedure: Internal urethrotomy Drug: Mitomycin C - local injection Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

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

Study Start Date: June 2009
Arms Assigned Interventions
Active Comparator: 1. Internal urethrotomy Procedure: Internal urethrotomy
Experimental: 2. Internal urethrotomy + mitomycin C Procedure: Internal urethrotomy Drug: Mitomycin C - local injection

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Nachum Erlich, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00918528     History of Changes
Other Study ID Numbers: 0020-09-HYMC
First Submitted: June 9, 2009
First Posted: June 11, 2009
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