Role of Paclitaxel in Stricture Urethra

Al-Azhar University

Status: Enrolling

Conditions: Stricture Urethra

Treatments: Procedure: DVIU; Procedure: DVIU with paclitaxel injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05678413

Intraurethral Paclitaxel

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

DVIU with paclitaxel

Active Comparator group

Description:

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.

Treatment:

Procedure: DVIU with paclitaxel injection

DVIU

Active Comparator group

Description:

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.

Treatment:

Procedure: DVIU