COX-2 InhibitorNCT06697106
Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
A study testing Nonsteroidal anti-inflammatory drugs in people with COX-2 Inhibitor and Meloxicam, run by New Valley University at 1 site in Egypt.
Trial summary
To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- COX-2 Inhibitor, Meloxicam, Stricture Recurrence
- What is being tested?
- Nonsteroidal anti-inflammatory drugs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) score ≤3.
- Urethral stricture length ≤ 1.5 cm
Who cannot join
- Recurrent urethral stricture ≥ 2 times.
- Pelvic fracture urethral distraction defect (PFUDD).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
New Valley University
New Valley, New Valley Governorate, 72511
Waheed F Abdelrasol, MD, 00201207722518, waheed_fawzy@med.nvu.edu.eg
About this study
To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.
Read the 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
- Being tested
- Nonsteroidal anti-inflammatory drugs, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsteroidal anti-inflammatory drugsDrug
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
PlaceboDrug
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nonsteroidal anti-inflammatory drugs | Experimental | Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks. Receives: Drug: Nonsteroidal anti-inflammatory drugs |
| Control group | Placebo comparator | Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days postoperative
Secondary outcomes (4)
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.
Measured: 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).
Measured: 90 days postoperative
Maximum flow rate
Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS).
Measured: 90 days postoperative
Incidence of complications
Incidence of complications will be recorded.
Measured: 90 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start20 Nov 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COX-2 InhibitorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waheed Fawzy Abdelrasol, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697106
- Sponsor's protocol ID
- 20241030012
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
- ClinicalTrials.gov ID
- NCT06697106
- Acronym / sponsor ID
- 20241030012
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonsteroidal anti-inflammatory drugs | Experimental | Drug: Nonsteroidal anti-inflammatory drugsPatients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks. |
| Control group | Placebo comparator | Drug: PlaceboPatients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) score ≤3.
- Urethral stricture length ≤ 1.5 cm
Key exclusion criteria (2 listed)
- Recurrent urethral stricture ≥ 2 times.
- Pelvic fracture urethral distraction defect (PFUDD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonsteroidal anti-inflammatory drugsPatients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks. | Drug | Nonsteroidal anti-inflammatory drugs |
| PlaceboPatients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks. | Drug | Control group |
Primary outcome
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.
4 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: 90 days postoperative
Quality of life (QOL)
Time frame: 90 days postoperative
Maximum flow rate
Time frame: 90 days postoperative
Incidence of complications
Time frame: 90 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonsteroidal anti-inflammatory drugs in people with COX-2 Inhibitor and Meloxicam, run by New Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waheed F Abdelrasol, MD (00201207722518, waheed_fawzy@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethral stricture recurrence (time frame: 90 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.