Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nonsteroidal anti-inflammatory drugs, Placebo.
- Who it may be relevant to
- Registry conditions: COX-2 Inhibitor, Meloxicam, Stricture Recurrence, Direct Vision Internal Urethrotomy. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.
Detailed 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
Interventions
- Drug Nonsteroidal anti-inflammatory drugs
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks. - Drug Placebo
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
Primary outcome measures
- Urethral stricture recurrence [Time frame: 90 days postoperative]
Secondary outcome measures (4)
- International Prostate Symptom Score (IPSS) [Time frame: 90 days postoperative]
- Quality of life (QOL) [Time frame: 90 days postoperative]
- Maximum flow rate [Time frame: 90 days postoperative]
- Incidence of complications [Time frame: 90 days postoperative]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- New Valley University — New Valley
Identifiers
NCT: NCT06697106 · 20241030012