What is the COX-2 inhibitor studying for urethral stricture recurrence?

This trial is studying whether a COX-2 inhibitor given after surgery can reduce the chance of urethral strictures coming back. Researchers want to see if adding this drug after direct vision internal urethrotomy helps prevent recurrence. The study is sponsored by New Valley University.

Who may be eligible for this urethral stricture clinical trial?

Men aged 18 years or older with a urethral stricture 1.5 cm or shorter may be eligible. Participants must have an ASA score of 3 or less and no more than one previous stricture recurrence. Those with pelvic fracture urethral distraction defects are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this urethral stricture clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

MALE

ID06697106

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

Led by New Valley University · Updated on 2024-11-21

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of nonsteroidal anti-inflammatory drugs (NSAIDs), specifically a COX-2 inhibitor, to prevent the recurrence of urethral strictures after direct visual internal urethrotomy (DVIU). Urethral strictures often result from idiopathic causes or medical procedures and have higher recurrence rates in certain conditions, such as multiple or long strictures and infections. This study aims to assess the safety and effectiveness of NSAIDs in reducing stricture recurrence following surgery. Participants will be randomly assigned to one of two groups. One group will receive DVIU followed by NSAIDs for three weeks, while the other group will receive DVIU followed by a placebo for the same duration. The study uses a single-blind design where participants do not know which treatment they receive. The treatments are given postoperatively to compare their effect on preventing stricture recurrence. During the study, participants will be monitored for urethral stricture recurrence 90 days after surgery. Additional assessments include symptom scores using the International Prostate Symptom Score (IPSS), quality of life evaluations, maximum urine flow rate, and any complications occurring within 90 days postoperatively. This follow-up period allows researchers to evaluate treatment impact and safety over three months.