<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03831321</url>
  </required_header>
  <id_info>
    <org_study_id>MedeniyetUro</org_study_id>
    <nct_id>NCT03831321</nct_id>
  </id_info>
  <brief_title>The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy</brief_title>
  <official_title>The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taha Uçar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medeniyet University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was designed as a prospective, randomized double-blind placebo controlled trial.&#xD;
      According to power analysis in regards of previous studies in the literature with diclofenac&#xD;
      sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05.&#xD;
      diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2&#xD;
      individually. Patient randomization was performed using random.org in 144 patients. On the&#xD;
      day of cystoscopy, the patient randomized according to inclusion criteria will be given a&#xD;
      medication package corresponding to the number given in randomization. It will not be known&#xD;
      by the staff and cystoscopy will be performed by the physician who does not know which&#xD;
      package is an effective drug.&#xD;
&#xD;
      Parameters:&#xD;
&#xD;
        1. Visual Pain Score during cystoscopy&#xD;
&#xD;
        2. Cystoscopy comfort - a questionnaire to be filled by the doctor&#xD;
&#xD;
             1. Excellent&#xD;
&#xD;
             2. Very good&#xD;
&#xD;
             3. Good&#xD;
&#xD;
             4. Bad&#xD;
&#xD;
             5. Too bad&#xD;
&#xD;
        3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.&#xD;
&#xD;
      Post-Op:&#xD;
&#xD;
        1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency&#xD;
&#xD;
        2. 24th Hour dysuria, Frequency,&#xD;
&#xD;
      A total of 144 patients, we plan to arrive at the end of 1 month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Anticipated">May 22, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 22, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Double blind placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assesment for operational pain</measure>
    <time_frame>1 minute</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assesment of doctors comfort for the procedure(cystoscopy)</measure>
    <time_frame>1 minute</time_frame>
    <description>It is subjective, It will made by a question which will be graded by the blind operator.&#xD;
The operator will choose one of the 5 answers. Scoring system will be range 1 to 5 and higher scores mean worse results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assesment of qualification of cystoscopy</measure>
    <time_frame>1 minute</time_frame>
    <description>It is subjective. It will be made by a question which will be answered by blind operator.&#xD;
The operator will choose one of the answers which are &quot;adequate or not adequate&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Bladder Cancer</condition>
  <condition>Benign Prostate Hyperplasia</condition>
  <condition>Hematuria</condition>
  <condition>Pain</condition>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Diclofenac group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium</intervention_name>
    <description>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.</description>
    <arm_group_label>Diclofenac group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cystoscopy</intervention_name>
    <description>Diagnostic cystoscopy</description>
    <arm_group_label>Diclofenac group</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lubricant Gel</intervention_name>
    <description>To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)</description>
    <arm_group_label>Diclofenac group</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accepted to participate&#xD;
&#xD;
          -  18-70 years old&#xD;
&#xD;
          -  Men&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous peptic ulcer&#xD;
&#xD;
          2. Gastro intestinal bleeding in advance&#xD;
&#xD;
          3. Renal failure&#xD;
&#xD;
          4. Liver failure&#xD;
&#xD;
          5. Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug&#xD;
             allergies&#xD;
&#xD;
        7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9-&#xD;
        Patients who do not agree to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asıf Yıldırım</last_name>
    <role>Study Director</role>
    <affiliation>Medeniyet University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Taha Uçar</last_name>
    <phone>05353044736</phone>
    <email>ucartaha@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medeniyet University</name>
      <address>
        <city>Istanbul</city>
        <state>Outside U.S./Canada</state>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taha Uçar</last_name>
      <phone>5353044736</phone>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 3, 2019</last_update_submitted>
  <last_update_submitted_qc>February 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Taha Uçar</investigator_full_name>
    <investigator_title>Resident Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematuria</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03831321
org study id: MedeniyetUro
nct id: NCT03831321
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
masking description: Double blind placebo controlled
measure: Assesment for operational pain
time frame: 1 minute
description: 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.
measure: Assesment of doctors comfort for the procedure(cystoscopy)
time frame: 1 minute
description: 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.
measure: Assesment of qualification of cystoscopy
time frame: 1 minute
description: 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".
arm group label: Diclofenac group
arm group type: Active Comparator
description: The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
arm group label: Placebo
arm group type: Placebo Comparator
description: The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
intervention type: Drug
intervention name: Diclofenac Sodium
description: 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.
arm group label: Diclofenac group
intervention type: Device
intervention name: Cystoscopy
description: Diagnostic cystoscopy
arm group label: Diclofenac group
arm group label: Placebo
intervention type: Drug
intervention name: Lubricant Gel
description: To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)
arm group label: Diclofenac group
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Asıf Yıldırım
role: Study Director
affiliation: Medeniyet University
last name: Taha Uçar
phone: 05353044736
email: ucartaha@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Taha Uçar
investigator title: Resident Doctor
mesh term: Hematuria
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
mesh term: Diclofenac
sharing ipd: Undecided