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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 9, 2009
Last Updated Date	June 10, 2009
Start Date ^ICMJE	June 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2009)	Urethral stricture recurrence [ Time Frame: One year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00918528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Urethral Stricture
Intervention ^ICMJE	Procedure: Internal urethrotomy Drug: Mitomycin C - local injection
Study Arm (s)	Active Comparator: 1. Internal urethrotomy Intervention: Procedure: Internal urethrotomy Experimental: 2. Internal urethrotomy + mitomycin C Interventions: Procedure: Internal urethrotomy Drug: Mitomycin C - local injection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00918528
Other Study ID Numbers ^ICMJE	0020-09-HYMC
Has Data Monitoring Committee	Not Provided
Responsible Party	Nachum Erlich, Hillel Yaffe Medical Center
Study Sponsor ^ICMJE	Hillel Yaffe Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hillel Yaffe Medical Center
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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