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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03831321
Other study ID # MedeniyetUro
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 11, 2018
Est. completion date May 22, 2019

Study information

Verified date February 2019
Source Istanbul Medeniyet University
Contact Taha Uçar
Phone 05353044736
Email ucartaha@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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:

1. Visual Pain Score during cystoscopy

2. Cystoscopy comfort - a questionnaire to be filled by the doctor

1. Excellent

2. Very good

3. Good

4. Bad

5. Too bad

3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.

Post-Op:

1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency

2. 24th Hour dysuria, Frequency,

A total of 144 patients, we plan to arrive at the end of 1 month.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date May 22, 2019
Est. primary completion date April 22, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Accepted to participate

- 18-70 years old

- Men

Exclusion Criteria:

1. Previous peptic ulcer

2. Gastro intestinal bleeding in advance

3. Renal failure

4. Liver failure

5. 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

Study Design


Intervention

Drug:
Diclofenac Sodium
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.
Device:
Cystoscopy
Diagnostic cystoscopy
Drug:
Lubricant Gel
To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)

Locations

Country Name City State
Turkey Medeniyet University Istanbul Outside U.S./Canada

Sponsors (1)

Lead Sponsor Collaborator
Taha Uçar

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 minute
Secondary 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.
1 minute
Secondary 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".
1 minute
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