Role of Paclitaxel in Stricture Urethra

NCT05678413 | Recruiting

• 1 other identifier: Intraurethral Paclitaxel
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stricture Urethra

Keywords

DVIU, Stricture, Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Success of treatment

  Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).

  1 year

Study Arms (2)

DVIU with paclitaxel

ACTIVE COMPARATOR

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

DVIU

ACTIVE COMPARATOR

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

Interventions

DVIU with paclitaxel injection PROCEDURE

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 with paclitaxel

DVIU PROCEDURE

DVIU

DVIU

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mohamed Fawzy Salman

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Urethral Stricture; Constriction, Pathologic

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Mohamed F Salman, MD

CONTACT

+201111788996; prof_mohamed_fawzy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 10, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

EG (1)