Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

NCT ID: NCT00918528

Last Updated: 2009-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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

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Conditions

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Urethral Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Internal urethrotomy

Group Type ACTIVE_COMPARATOR

Internal urethrotomy

Intervention Type PROCEDURE

2. Internal urethrotomy + mitomycin C

Group Type EXPERIMENTAL

Internal urethrotomy

Intervention Type PROCEDURE

Mitomycin C - local injection

Intervention Type DRUG

Interventions

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Internal urethrotomy

Intervention Type PROCEDURE

Mitomycin C - local injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Michael Mullerad, MD

Role: primary

972-4-630-4440

Nachum Erlich, MD

Role: backup

972-4-630-4440

Other Identifiers

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0020-09-HYMC

Identifier Type: -

Identifier Source: org_study_id

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