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

NCT ID: NCT06697106

Last Updated: 2024-11-21

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-04-01

Brief Summary

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

Detailed Description

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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

Conditions

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COX-2 Inhibitor Meloxicam Stricture Recurrence Direct Vision Internal Urethrotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Nonsteroidal anti-inflammatory drugs

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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New Valley University

OTHER

Sponsor Role lead

Responsible Party

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Waheed Fawzy Abdelrasol

Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New Valley University

New Valley, New Valley Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Waheed F Abdelrasol, MD

Role: CONTACT

00201207722518

Facility Contacts

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Waheed F Abdelrasol, MD

Role: primary

00201207722518

Other Identifiers

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20241030012

Identifier Type: -

Identifier Source: org_study_id

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