Role of Paclitaxel in Stricture Urethra

Stricture Urethra Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678413
• Other study ID #: Intraurethral Paclitaxel
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2022
• Source: Al-Azhar University
• Contact: Mohamed F Salman, MD
• Phone: +201111788996
• Email: prof_mohamed_fawzy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stricture Urethra
• Urethral Stricture

Intervention

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.
• DVIU
DVIU

Locations

Country	Name	City	State
Egypt	Mohamed Fawzy Salman	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of treatment	Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).	1 year