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

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06232005
• Other study ID #: MS 604/2022
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Drug:
• Mitomycin c
injection of antifibrotic drugs in urethral strictures after internal urethrotomy

Locations

Country	Name	City	State
Egypt	Ahmed Maher	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	urinary tract infection	post operative complication confirmed by urine culture	1 month
Secondary	uroflowmetery	evaluate of the urine flow during the follow up period	1 year