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

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

Study Overview

• Status: Recruiting
• Conditions: COX-2 Inhibitor; Meloxicam; Stricture Recurrence; Direct Vision Internal Urethrotomy
• Intervention / Treatment: Drug: Nonsteroidal anti-inflammatory drugs; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Waheed F Abdelrasol, MD; Phone Number: 00201207722518; Email: waheed_fawzy@med.nvu.edu.eg

Study Locations

• Egypt
  • New Valley, Egypt, 72511
    • Recruiting
    • New Valley University
    • Contact: Waheed F Abdelrasol, MD; Phone Number: 00201207722518; Email: waheed_fawzy@med.nvu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nonsteroidal anti-inflammatory drugs; Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.	Drug: Nonsteroidal anti-inflammatory drugs; Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
Placebo Comparator: Control group; Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.	Drug: Placebo; Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	The International Prostate Symptom Score (IPSS) will be used to assess lower urinary tract symptoms (LUTS). The IPSS consists of seven questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.	90 days postoperative
Quality of life (QOL)	Quality of life (QOL) will be used to assess lower urinary tract symptoms (LUTS). Patients will answer using a Likert scale, with four or five response options per item, and scores range from 0 (best QoL) to 13 (worst QoL).	90 days postoperative
Maximum flow rate	Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS).	90 days postoperative
Incidence of complications	Incidence of complications will be recorded.	90 days postoperative

Collaborators and Investigators

• Sponsor: New Valley University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Disease Attributes; Recurrence; Constriction, Pathologic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: 20241030012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No