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Role of Paclitaxel in Stricture Urethra

NCT05678413 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-15

No results posted yet for this study

Summary

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.

Conditions

  • Stricture Urethra

Interventions

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.

PROCEDURE

DVIU

DVIU

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-06-01
Completion
2025-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678413 on ClinicalTrials.gov