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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
144
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.
Diagnostic cystoscopy
To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)
Medeniyet University
Istanbul, Outside U.S./Canada, Turkey (Türkiye)
RECRUITINGAssesment 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.
Time frame: 1 minute
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.
Time frame: 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".
Time frame: 1 minute
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