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

Phase 2

Completed

• Conditions: Urethral Stricture
• Interventions: Drug: Mitomycin c

• Registration Number: NCT06232005
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy only.	Mitomycin c	Standard procedure of visual internal urethrotomy only for urethral stricture
25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy with intralesio	Mitomycin c	intralesional injection of mitomycin-c following the standard visual internal urethrotomy

Primary Outcome Measures

Name	Time	Method
Urethral stricture recurrence	1 year	is defined as recurrence of LUTS during follow-up visits starting at 3 months till 12 months with difficulty of passing urine and confirmed by a voiding cystourethrogram.

Secondary Outcome Measures

Name	Time	Method
urinary tract infection	1 month	post operative complication confirmed by urine culture
uroflowmetery	1 year	evaluate of the urine flow during the follow up period

Trial Locations

Locations (1)

Ahmed Maher; 🇪🇬 Cairo, القاهرة, Egypt