Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00918528
First received: June 9, 2009
Last updated: June 10, 2009
Last verified: June 2009
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nachum Erlich, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00918528     History of Changes
Other Study ID Numbers: 0020-09-HYMC
Study First Received: June 9, 2009
Last Updated: June 10, 2009
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 23, 2014