NCT00918528

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

First QC Date

June 9, 2009

Last Update Submit

June 10, 2009

Conditions

Urethral Stricture

Keywords

Urethral strictureMitomycin CInternal Urethrotomy

Outcome Measures

Primary Outcomes (1)

  • Urethral stricture recurrence

    One year

Study Arms (2)

1. Internal urethrotomy

ACTIVE COMPARATOR
Procedure: Internal urethrotomy

2. Internal urethrotomy + mitomycin C

EXPERIMENTAL
Procedure: Internal urethrotomyDrug: Mitomycin C - local injection

Interventions

Internal urethrotomyPROCEDURE
1. Internal urethrotomy2. Internal urethrotomy + mitomycin C
Mitomycin C - local injectionDRUG
2. Internal urethrotomy + mitomycin C

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male urethral stricture suitable for internal urethrotomy
  • Stricture length less than 10 mm

You may not qualify if:

  • Stricture length over 10 mm
  • Benign prostate enlargement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

June 1, 2009

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

IL(1)