Back to resultsEffect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
Primary Purpose
Urethral Stricture
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Internal urethrotomy
Mitomycin C - local injection
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture focused on measuring Urethral stricture, Mitomycin C, Internal Urethrotomy
Eligibility 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
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1. Internal urethrotomy
2. Internal urethrotomy + mitomycin C
Arm Description
Outcomes
Primary Outcome Measures
Urethral stricture recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT00918528
First Posted
June 9, 2009
Last Updated
June 10, 2009
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00918528
Brief Title
Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
Keywords
Urethral stricture, Mitomycin C, Internal Urethrotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1. Internal urethrotomy
Arm Type
Active Comparator
Arm Title
2. Internal urethrotomy + mitomycin C
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Internal urethrotomy
Intervention Type
Drug
Intervention Name(s)
Mitomycin C - local injection
Primary Outcome Measure Information:
Title
Urethral stricture recurrence
Time Frame
One year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mullerad, MD
Phone
972-4-630-4440
First Name & Middle Initial & Last Name & Degree
Nachum Erlich, MD
Phone
972-4-630-4440
Email
erlichn@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Michael Mullerad, MD
First Name & Middle Initial & Last Name & Degree
Nachum Erlich, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
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