<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/NCT03833752</url>
  </required_header>
  <id_info>
    <org_study_id>F.No./11IEC/MAMC/2016/113</org_study_id>
    <nct_id>NCT03833752</nct_id>
  </id_info>
  <brief_title>Flexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection</brief_title>
  <official_title>Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maulana Azad Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maulana Azad Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to perform a randomized study, comparing the outcomes of the&#xD;
      above two types of cystoscopy in terms of discomfort experienced by the patient, while&#xD;
      undergoing the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cystoscopy is a commonly performed routine outpatient procedure and an essential diagnostic&#xD;
      tool in urology.Compared with flexible endoscopes, rigid instruments offer better image&#xD;
      quality, a wider lumen of the working channel, improved irrigant flow and superior handiness.&#xD;
      However, flexible cystoscopes provide more options for patient positioning, enable smooth&#xD;
      passage over an elevated bladder neck or median lobe, facilitate full inspection of the&#xD;
      bladder because of their movable tip and, what is most important is it significantly improve&#xD;
      patient comfort(patient can be positioned in any comfortable position).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Procedure Discomfort</measure>
    <time_frame>periprocedure</time_frame>
    <description>Discomfort experienced immediately post procedure by the patient defined as a Visual Analogue Scale score of more than 3 (range is from 1 to 10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Procedure</measure>
    <time_frame>periprocedure</time_frame>
    <description>time taken to complete the entire test in minutes starting from insertion of the cystoscope through the urethral meatus, visualising the entire bladder and urethra , till the removal of the scope after making the observations.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Flexible Cystoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diagnostic flexible cystoscopy for the patients in this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rigid Cystoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diagnostic rigid cystoscopy is done for the patients in this arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic Flexible Cystosocpy</intervention_name>
    <description>Endoscopic Visualization of the Lower Urinary tract using either a flexible cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.</description>
    <arm_group_label>Flexible Cystoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic Rigid Cystoscopy</intervention_name>
    <description>Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.</description>
    <arm_group_label>Rigid Cystoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with lower urinary tract symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with Suprapubic catheter&#xD;
&#xD;
          -  History of radical prostatectomy or cystoprostatectomy&#xD;
&#xD;
          -  Clinical evidence of urethral stricture, prostatitis&#xD;
&#xD;
          -  Patients with bacterial growth on urine culture&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PAWAN LAL, MS,DNB,DA</last_name>
    <role>Study Director</role>
    <affiliation>Professor, Department of Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maulana Aazad Medical College</name>
      <address>
        <city>New Delhi</city>
        <zip>110002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maulana Azad Medical College</investigator_affiliation>
    <investigator_full_name>Dr. Gaurish Sawant</investigator_full_name>
    <investigator_title>resident doctor</investigator_title>
  </responsible_party>
  <keyword>rigid cystoscopy</keyword>
  <keyword>flexible cystosocpy</keyword>
  <keyword>UTI</keyword>
  <keyword>BPH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared to all researchers who produce the query for it.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03833752
org study id: F.No./11IEC/MAMC/2016/113
nct id: NCT03833752
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to perform a randomized study, comparing the outcomes of the
      above two types of cystoscopy in terms of discomfort experienced by the patient, while
      undergoing the procedure.
Cystoscopy is a commonly performed routine outpatient procedure and an essential diagnostic
      tool in urology.Compared with flexible endoscopes, rigid instruments offer better image
      quality, a wider lumen of the working channel, improved irrigant flow and superior handiness.
      However, flexible cystoscopes provide more options for patient positioning, enable smooth
      passage over an elevated bladder neck or median lobe, facilitate full inspection of the
      bladder because of their movable tip and, what is most important is it significantly improve
      patient comfort(patient can be positioned in any comfortable position).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Post Procedure Discomfort
time frame: periprocedure
description: Discomfort experienced immediately post procedure by the patient defined as a Visual Analogue Scale score of more than 3 (range is from 1 to 10)
measure: Duration of Procedure
time frame: periprocedure
description: time taken to complete the entire test in minutes starting from insertion of the cystoscope through the urethral meatus, visualising the entire bladder and urethra , till the removal of the scope after making the observations.
arm group label: Flexible Cystoscopy
arm group type: Experimental
description: Diagnostic flexible cystoscopy for the patients in this arm
arm group label: Rigid Cystoscopy
arm group type: Active Comparator
description: Diagnostic rigid cystoscopy is done for the patients in this arm
intervention type: Diagnostic Test
intervention name: Diagnostic Flexible Cystosocpy
description: Endoscopic Visualization of the Lower Urinary tract using either a flexible cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
arm group label: Flexible Cystoscopy
intervention type: Diagnostic Test
intervention name: Diagnostic Rigid Cystoscopy
description: Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
arm group label: Rigid Cystoscopy
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: PAWAN LAL, MS,DNB,DA
role: Study Director
affiliation: Professor, Department of Surgery
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Maulana Azad Medical College
investigator full name: Dr. Gaurish Sawant
investigator title: resident doctor
mesh term: Lower Urinary Tract Symptoms
sharing ipd: Yes
ipd description: IPD will be shared to all researchers who produce the query for it.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)