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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831321
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Taha Uçar, Istanbul Medeniyet University

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 11, 2018
Estimated Primary Completion Date : April 22, 2019
Estimated Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Assesment for operational pain [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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".




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831321


Contacts
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Contact: Taha Uçar 05353044736 ucartaha@gmail.com

Locations
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Turkey
Medeniyet University Recruiting
Istanbul, Outside U.S./Canada, Turkey
Contact: Taha Uçar    5353044736      
Sponsors and Collaborators
Taha Uçar
Investigators
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Study Director: Asıf Yıldırım Medeniyet University

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Responsible Party: Taha Uçar, Resident Doctor, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT03831321    
Other Study ID Numbers: MedeniyetUro
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Prostatic Hyperplasia
Hematuria
Hyperplasia
Lower Urinary Tract Symptoms
Urologic Diseases
Pathologic Processes
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Hemorrhage
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action