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Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

H

Hillel Yaffe Medical Center

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Urethral Stricture

Treatments

Drug: Mitomycin C - local injection
Procedure: Internal urethrotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00918528
0020-09-HYMC

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

1. Internal urethrotomy
Active Comparator group
Treatment:
Procedure: Internal urethrotomy
2. Internal urethrotomy + mitomycin C
Experimental group
Treatment:
Procedure: Internal urethrotomy
Drug: Mitomycin C - local injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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