COX-2 Inhibitor, Direct Vision Internal Urethrotomy, Meloxicam, Stricture Recurrence
Conditions
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
Interventions
DRUGNonsteroidal anti-inflammatory drugs
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
DRUGPlacebo
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
Sponsors
New Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Maximum flow rate | 90 days postoperative | Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS). |
| Incidence of complications | 90 days postoperative | Incidence of complications will be recorded. |
Countries
Egypt
Contacts
Primary ContactWaheed F Abdelrasol, MD
Outcome results
None listed