Bladder CancerPhase 4NCT03831321
The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
A Phase 4 study testing Diclofenac Sodium, Cystoscopy and Lubricant Gel in people with Bladder Cancer and Benign Prostate Hyperplasia, run by Taha Uçar at 1 site in Turkey (Türkiye).
Trial summary
The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Bladder Cancer, Benign Prostate Hyperplasia, Hematuria
- What is being tested?
- Diclofenac Sodium, Cystoscopy and Lubricant Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2018to 22 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accepted to participate
- 18-70 years old
- Men
Who cannot join
- Previous peptic ulcer
- Gastro intestinal bleeding in advance
- Renal failure
- Liver failure
- Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug allergies
- 7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9- Patients who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medeniyet University
Istanbul, Outside U.S./Canada
Taha Uçar, 5353044736
About this study
The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug.
Parameters:
Read more
- Visual Pain Score during cystoscopy
- Cystoscopy comfort - a questionnaire to be filled by the doctor
- Excellent
- Very good
- Good
- Bad
- Too bad
- Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.
Post-Op:
- 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency
- 24th Hour dysuria, Frequency,
A total of 144 patients, we plan to arrive at the end of 1 month.
- Conditions
- Bladder Cancer, Benign Prostate Hyperplasia, Hematuria, Pain, Lower Urinary Tract Symptoms
- Being tested
- Diclofenac Sodium, Cystoscopy, Lubricant Gel
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Hyperplasia, Hematuria, Pain, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
50 mg of diclofenac sodium will be administered to intervention group one hour before cystoscopy and lubricant gel with lidocaine will be administered to all patients just before cystoscopy.
CystoscopyDevice
Diagnostic cystoscopy
Lubricant GelDrug
To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac group | Active comparator | The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local Receives: Drug: Diclofenac Sodium; Device: Cystoscopy; Drug: Lubricant Gel |
| Placebo | Placebo comparator | The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy Receives: Device: Cystoscopy; Drug: Lubricant Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment for operational pain
All the patients will be assessed with Visual pain scale during cystoscopy procedure Scale is a well know pain assesment form which is ranged between 0 to 10 points and higher scores mean worse pain.
Measured: 1 minute
Secondary outcomes (2)
Assesment of doctors comfort for the procedure(cystoscopy)
It is subjective, It will made by a question which will be graded by the blind operator.
The operator will choose one of the 5 answers. Scoring system will be range 1 to 5 and higher scores mean worse results.
Measured: 1 minute
Assesment of qualification of cystoscopy
It is subjective. It will be made by a question which will be answered by blind operator.
The operator will choose one of the answers which are "adequate or not adequate".
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start11 Dec 2018
- Primary completion22 Apr 2019 (estimated)
- Study completion22 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taha Uçar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taha Uçar, Istanbul Medeniyet University
- Investigators
- Asıf Yıldırım, Study director, Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831321
- Sponsor's protocol ID
- MedeniyetUro
- Status last verified
- Feb 2019
- First submitted
- 1 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
- ClinicalTrials.gov ID
- NCT03831321
- Acronym / sponsor ID
- MedeniyetUro
- Conditions
- Bladder Cancer, Benign Prostate Hyperplasia, Hematuria, Pain, Lower Urinary Tract Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Taha UçarUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 22 Apr 2019 (estimated)
- Study completion
- 22 May 2019 (estimated)
- First posted
- 5 Feb 2019 (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.
The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug.
Parameters:
- Visual Pain Score during cystoscopy
- Cystoscopy comfort - a questionnaire to be filled by the doctor
- Excellent
- Very good
- Good
- Bad
- Too bad
- Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.
Post-Op:
- 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency
- 24th Hour dysuria, Frequency,
A total of 144 patients, we plan to arrive at the end of 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac group | Active comparator | Drug: Diclofenac Sodium, Device: Cystoscopy, Drug: Lubricant GelThe group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local |
| Placebo | Placebo comparator | Device: Cystoscopy, Drug: Lubricant GelThe group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Accepted to participate
- 18-70 years old
- Men
Key exclusion criteria (6 listed)
- Previous peptic ulcer
- Gastro intestinal bleeding in advance
- Renal failure
- Liver failure
- Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug allergies
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 |
|---|---|---|
| Diclofenac Sodium50 mg of diclofenac sodium will be administered to intervention group one hour before cystoscopy and lubricant gel with lidocaine will be administered to all patients just before cystoscopy. | Drug | Diclofenac group |
| CystoscopyDiagnostic cystoscopy | Device | Diclofenac group, Placebo |
| Lubricant GelTo prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort) | Drug | Diclofenac group, Placebo |
Primary outcome
Assesment for operational pain
Time frame: 1 minute
All the patients will be assessed with Visual pain scale during cystoscopy procedure Scale is a well know pain assesment form which is ranged between 0 to 10 points and higher scores mean worse pain.
2 secondary outcomes
Assesment of doctors comfort for the procedure(cystoscopy)
Time frame: 1 minute
Assesment of qualification of cystoscopy
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Asıf Yıldırım study director
Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac Sodium, Cystoscopy and Lubricant Gel in people with Bladder Cancer and Benign Prostate Hyperplasia, run by Taha Uçar at 1 site in Turkey (Türkiye).
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 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taha Uçar (05353044736, ucartaha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment for operational pain (time frame: 1 minute). 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 5 Feb 2019.