The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

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 Overview

• Status: Unknown
• Conditions: Pain; Lower Urinary Tract Symptoms; Bladder Cancer; Benign Prostate Hyperplasia; Hematuria
• Intervention / Treatment: Drug: Diclofenac Sodium; Device: Cystoscopy; Drug: Lubricant Gel

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Taha Uçar; Phone Number: 05353044736; Email: ucartaha@gmail.com

Study Locations

• Turkey
  • Outside U.S./Canada
    • Istanbul, Outside U.S./Canada, Turkey
      • Recruiting
      • MEDENIYET UNIVERSITY
      • Contact: Taha Uçar; Phone Number: 5353044736

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diclofenac group; The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local	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)
PLACEBO_COMPARATOR: Placebo; The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy	Device: Cystoscopy; Diagnostic cystoscopy; Drug: Lubricant Gel; To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Taha Uçar
• Investigators: Study Director: Asıf Yıldırım, MEDENIYET UNIVERSITY

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2018
• Primary Completion (ANTICIPATED): April 22, 2019
• Study Completion (ANTICIPATED): May 22, 2019

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: February 3, 2019
• First Posted (ACTUAL): February 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 3, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urological Manifestations; Hemorrhage; Prostatic Diseases; Urination Disorders; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Hematuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: MedeniyetUro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes