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

NCT06697106 | Recruiting

• 1 other identifier: 20241030012
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Urethral stricture recurrence

  Urethral stricture recurrence is defined as the need for a secondary procedure, including dilation, internal urethrotomy, and urethroplasty, considered as treatment failure.

  90 days postoperative

Secondary Outcomes (4)

• International Prostate Symptom Score (IPSS)

  90 days postoperative

• Quality of life (QOL)

  90 days postoperative

• Maximum flow rate

  90 days postoperative

• Incidence of complications

  90 days postoperative

Study Arms (2)

Nonsteroidal anti-inflammatory drugs

EXPERIMENTAL

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

Drug: Nonsteroidal anti-inflammatory drugs

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Nonsteroidal anti-inflammatory drugs DRUG

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

Nonsteroidal anti-inflammatory drugs

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males undergoing direct vision internal urethrotomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) score ≤3.
• Urethral stricture length ≤ 1.5 cm

You may not qualify if:

• Recurrent urethral stricture ≥ 2 times.
• Pelvic fracture urethral distraction defect (PFUDD).

Sponsors & Collaborators

• New Valley University: lead

Study Sites (1)

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

RECRUITING

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Central Study Contacts

Waheed F Abdelrasol, MD

CONTACT

00201207722518; waheed_fawzy@med.nvu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: November 20, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)