Role of Paclitaxel in Stricture Urethra

Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial

Stricture urethra is a common disease and has various causing factors. The most common performed procedure is direct visual internal urethrotomy (DVIU), but unfortunately has a high recurrence rates. Multiple trial were performed to improve the outcomes of DVIU. Various intralesional injections were used. in this trial we will evaluate intralesional paclitaxel injection following DVIU.

Study Overview

• Status: Recruiting
• Conditions: Stricture Urethra
• Intervention / Treatment: Procedure: DVIU with paclitaxel injection; Procedure: DVIU

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed F Salman, MD; Phone Number: +201111788996; Email: Prof_mohamed_fawzy@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Mohamed Fawzy Salman
    • Contact: Mohamed Fawzy Salman, MD; Phone Number: +201111788996; Email: prof_mohamed_fawzy@yahoo.com
    • Principal Investigator: Aboelfotoh A Aboelfoth, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Anterior urethral stricture
• Short strictures (less than 2 cm)
• International Prostate Symptom Score less than 11 and maximum flow rate < 15 ml per second.
• No previous treatment for stricture disease

Exclusion Criteria:

• Recurrent cases
• Prior pelvic radiation
• Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DVIU with paclitaxel; Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.	Procedure: DVIU with paclitaxel injection; Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.
Active Comparator: DVIU; Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue.	Procedure: DVIU; DVIU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of treatment	Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).	1 year

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: DVIU, Stricture, Paclitaxel
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constriction, Pathologic; Urethral Stricture; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: Intraurethral Paclitaxel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No