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

NCT06232005 | Completed Phase 2 DMC

• 1 other identifier: MS 604/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethral Stricture

Keywords

Mitomycin C - Visual Internal Urethrotomy - Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• Urethral stricture recurrence

  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.

  1 year

Secondary Outcomes (2)

• urinary tract infection

  1 month

• uroflowmetery

  1 year

Study Arms (2)

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

ACTIVE COMPARATOR

Standard procedure of visual internal urethrotomy only for urethral stricture

Drug: Mitomycin c

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

EXPERIMENTAL

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

Drug: Mitomycin c

Interventions

Mitomycin c DRUG

injection of antifibrotic drugs in urethral strictures after internal urethrotomy

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: surgery in male urethra
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher

Cairo, Cairo Governorate, 11757, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

EG (1)