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

Not Applicable

Recruiting

• Conditions: COX-2 Inhibitor; Meloxicam; Stricture Recurrence; Direct Vision Internal Urethrotomy
• Interventions: Drug: Nonsteroidal anti-inflammatory drugs; Drug: Placebo

• Registration Number: NCT06697106
• Lead Sponsor: New Valley University

Brief Summary

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

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-17
• Study First Submitted QC: 2024-11-17
• Study Start: 2024-11-20
• Study First Posted: 2024-11-20
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonsteroidal anti-inflammatory drugs	Nonsteroidal anti-inflammatory drugs	Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
Control group	Placebo	Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Urethral stricture recurrence	90 days postoperative	Urethral stricture recurrence is defined as the need for a secondary procedure, including dilation, internal urethrotomy, and urethroplasty, considered as treatment failure.

Secondary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	90 days postoperative	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.
Quality of life (QOL)	90 days postoperative	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).
Incidence of complications	90 days postoperative	Incidence of complications will be recorded.
Maximum flow rate	90 days postoperative	Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS).

Trial Locations

Locations (1)

New Valley University; 🇪🇬 New Valley, Egypt

New Valley University

🇪🇬New Valley, Egypt

Waheed F Abdelrasol, MD

Contact

00201207722518

waheed_fawzy@med.nvu.edu.eg