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

ConditionsCOX-2 InhibitorMeloxicamStricture RecurrenceDirect Vision Internal Urethrotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorNew Valley University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

American Society of Anesthesiologists (ASA) score ≤3.

Urethral stricture length ≤ 1.5 cm

Disqualifiers

Recurrent urethral stricture ≥ 2 times.

Pelvic fracture urethral distraction defect (PFUDD).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nonsteroidal anti-inflammatory drugs

    Drug

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

  • Placebo

    Drug

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

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Nonsteroidal anti-inflammatory drugsExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
90 days postoperative

Secondary outcomes

1

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.

Time frame
90 days postoperative
2

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).

Time frame
90 days postoperative
3

Maximum flow rate

Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS).

Time frame
90 days postoperative
4

Incidence of complications

Incidence of complications will be recorded.

Time frame
90 days postoperative

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

New Valley UniversityRecruiting72511, New Valley, New Valley GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New Valley University

Lead sponsor

Source ClinicalTrials.gov
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