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

A

Ain Shams University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Urethral Stricture

Treatments

Drug: Mitomycin c

Study type

Interventional

Funder types

Other

Identifiers

NCT06232005
MS 604/2022

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy only.
Active Comparator group
Description:
Standard procedure of visual internal urethrotomy only for urethral stricture
Treatment:
Drug: Mitomycin c
25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy with intralesio
Experimental group
Description:
intralesional injection of mitomycin-c following the standard visual internal urethrotomy
Treatment:
Drug: Mitomycin c

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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