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

• Sponsor: Taha Uçar (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03831321
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 27.1

Study Details

Study Description

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

3. Excellent

4. Very good

5. Good

6. Bad

7. Too bad

8. 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Benign Prostate Hyperplasia; Hematuria; Pain; Lower Urinary Tract Symptoms	Drug: Diclofenac Sodium; Device: Cystoscopy; Drug: Lubricant Gel	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Double blind placebo controlled
• Primary Purpose: Supportive Care
• Official Title: The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
• Actual Study Start Date: Dec 11, 2018
• Anticipated Primary Completion Date: Apr 22, 2019
• Anticipated Study Completion Date: May 22, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medeniyet University	Istanbul	Outside U.S./Canada	Turkey

Sponsors and Collaborators

• Taha Uçar

Investigators

• Study Director: Asıf Yıldırım, Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taha Uçar, Resident Doctor, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT03831321
• Other Study ID Numbers: MedeniyetUro
• First Posted: Feb 5, 2019
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Hematuria; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Diclofenac

Study Results

No Results Posted as of Feb 5, 2019