New Valley University
New Valley, New Valley Governorate, 72511, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT06697106
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Nonsteroidal anti-inflammatory drugs
DrugPatients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
Placebo
DrugPatients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
Primary outcomes
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Urethral stricture recurrence
Time frame: 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 outcomes
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International Prostate Symptom Score (IPSS)
Time frame: 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.
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Quality of life (QOL)
Time frame: 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).
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Maximum flow rate
Time frame: 90 days postoperative
Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS).
-
Incidence of complications
Time frame: 90 days postoperative
Incidence of complications will be recorded.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
New Valley University
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 20, 2024
- Registry last updated
- Nov 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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