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

New Valley University

Status: Enrolling

Conditions: Meloxicam; COX-2 Inhibitor; Stricture Recurrence; Direct Vision Internal Urethrotomy

Treatments: Drug: Nonsteroidal anti-inflammatory drugs; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06697106

20241030012

Details and patient eligibility

About

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

Full description

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

Enrollment: 82 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

82 participants in 2 patient groups, including a placebo group

Nonsteroidal anti-inflammatory drugs

Experimental group

Description:

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

Treatment:

Drug: Nonsteroidal anti-inflammatory drugs

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo