Clinical trial

Intralesional Injection of Mitomycin C Following Visual Internal Urethrotomy for Recurrent Urethral Stricture

NCT06232005

Name

MS 604/2022

Description

To evaluate the effectiveness of administering mitomycin C through intralesional injection after performing visual internal urethrotomy (VIU) for the treatment of recurring urethral stricture.

Trial arms

Trial start

2022-01-01

Estimated PCD

2023-01-01

Trial end

2023-12-01

Status

Completed

Phase

Early phase I

Treatment

Mitomycin c

injection of antifibrotic drugs in urethral strictures after internal urethrotomy

Arms:

25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy only., 25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy with intralesio

Size

Primary endpoint

Urethral stricture recurrence

1 year

Eligibility criteria

Inclusion Criteria: * All adult male patients aged above 18 years with a single bulbar urethral stricture measuring less than ( 1.5 cm), and had failed at least one prior intervention for urethral stricture(urethral dilation \& VIU) were included in our study Exclusion Criteria: * Patients with urethral strictures more than (1.5 cm), multiple urethral strictures, complex stricture, complicated by a fistula or abscess, completely occluded urethral strictures and previous urethroplasty were excluded

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

Updated at

2024-01-30

1 organization

1 product

1 indication

Organization

Ain Shams University

Product

Mitomycin C

Indication

Urethral Stricture