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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03831321
Study type Interventional
Source Istanbul Medeniyet University
Contact Taha Uçar
Phone 05353044736
Email ucartaha@gmail.com
Status Recruiting
Phase Phase 4
Start date December 11, 2018
Completion date May 22, 2019

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