Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
NCT ID: NCT06697106
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2024-11-20
2025-04-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Nonsteroidal anti-inflammatory drugs
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
Nonsteroidal anti-inflammatory drugs
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
Control group
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
Placebo
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
Interventions
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Nonsteroidal anti-inflammatory drugs
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
Placebo
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) score ≤3.
* Urethral stricture length ≤ 1.5 cm
Exclusion Criteria
* Pelvic fracture urethral distraction defect (PFUDD).
18 Years
MALE
No
Sponsors
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New Valley University
OTHER
Responsible Party
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Waheed Fawzy Abdelrasol
Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt
Locations
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New Valley University
New Valley, New Valley Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20241030012
Identifier Type: -
Identifier Source: org_study_id
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