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

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-01

Brief Summary

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

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Detailed Description

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Numerous studies have investigated the impact of intralesional administration of antifibrotic drugs on urethral strictures following visual internal urethrotomy (VIU). These drugs include mitomycin C, botulinum toxin A, somatostatin analog, and glucocorticoids. Mitomycin C (MMC) is known for its potent chemotherapeutic and antibiotic properties. It effectively hinders mitosis and fibroblast proliferation, playing a crucial role in tissue healing and scar formation by reducing the release of matrix proteins through the inhibition of proliferative fibroblasts. With its anti-proliferative and anti-scarring characteristics, MMC proves to be a suitable option for treating recurrent urethral strictures.

thus we conduct a randomized controlled trial to evaluate the safety and efficacy of Mitomycin in decrease urethral stricture recurrence.

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

DOUBLE

Participants Outcome Assessors

Study Groups

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

Standard procedure of visual internal urethrotomy only for urethral stricture

Group Type ACTIVE_COMPARATOR

Mitomycin c

Intervention Type DRUG

injection of antifibrotic drugs in urethral strictures after internal urethrotomy

25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy with intralesio

intralesional injection of mitomycin-c following the standard visual internal urethrotomy

Group Type EXPERIMENTAL

Mitomycin c

Intervention Type DRUG

injection of antifibrotic drugs in urethral strictures after internal urethrotomy

Interventions

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Mitomycin c

injection of antifibrotic drugs in urethral strictures after internal urethrotomy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No