Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?

New Valley University82 enrolled

Overview

To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.

The most common aetiology of urethral strictures is idiopathic, followed by iatrogenic causes, including transurethral resection, urethral catheterization, prostate cancer treatments, and previous hypospadias surgery. The recurrence rates are higher with previously treated, long and multiple strictures, penile compared with bulbar strictures, and those with perioperative infection. It has been reported that post-transurethral resection of the prostate (TURP) to receive or not receive a COX-2 inhibitor (rofecoxib 25 mg/day) for 20 days. At 1 year of follow-up, a urethral stricture had been diagnosed in 17 and 0 % of cases without and with COX-2 treatment, respectively

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

COX-2 Inhibitor Meloxicam Stricture Recurrence Direct Vision Internal Urethrotomy

Interventions

Nonsteroidal anti-inflammatory drugsDRUG

Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.

PlaceboDRUG

Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * American Society of Anesthesiologists (ASA) score ≤3. * Urethral stricture length ≤ 1.5 cm Exclusion Criteria: * Recurrent urethral stricture ≥ 2 times. * Pelvic fracture urethral distraction defect (PFUDD).

Locations (1)

New Valley University

New Valley, New Valley Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

Urethral stricture recurrence

Urethral stricture recurrence is defined as the need for a secondary procedure, including dilation, internal urethrotomy, and urethroplasty, considered as treatment failure.