Bladder Cancer, Benign Prostate Hyperplasia, Hematuria, Pain, Lower Urinary Tract Symptoms
Conditions
Brief 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.
Interventions
DRUGDiclofenac 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.
DEVICECystoscopy
Diagnostic cystoscopy
DRUGLubricant Gel
To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)
Sponsors
Taha Uçar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blind placebo controlled
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assesment for operational pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assesment of doctors comfort for the procedure(cystoscopy) | 1 minute | 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. |
| Assesment of qualification of cystoscopy | 1 minute | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTaha Uçar
Outcome results
None listed