Role of Paclitaxel in Stricture Urethra

Not Applicable

Recruiting

• Conditions: Stricture Urethra
• Interventions: Procedure: DVIU; Procedure: DVIU with paclitaxel injection

• Registration Number: NCT05678413
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-12-24
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DVIU	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.
DVIU with paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Success of treatment	1 year	Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).

Trial Locations

Locations (1)

Mohamed Fawzy Salman; 🇪🇬 Cairo, Egypt