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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
Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.
Post-Op:
A total of 144 patients, we plan to arrive at the end of 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac group | Active Comparator | The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local |
|
| Placebo | Placebo Comparator | The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assesment of qualification of cystoscopy |
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Inclusion Criteria:
Exclusion Criteria:
7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9- Patients who do not agree to participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taha Uçar | Contact | 05353044736 | ucartaha@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Asıf Yıldırım | Medeniyet University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medeniyet University | Recruiting | Istanbul | Outside U.S./Canada | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D011470 | Prostatic Hyperplasia |
| D006417 | Hematuria |
| D010146 | Pain |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double blind placebo controlled
| Cystoscopy | Device | Diagnostic cystoscopy |
|
| Lubricant Gel | Drug | To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort) |
|
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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D014555 | Urination Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020924 | Urological Manifestations |
| D004724 |
| Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |