<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/NCT03243682</url>
  </required_header>
  <id_info>
    <org_study_id>Bidirectional SWL</org_study_id>
    <nct_id>NCT03243682</nct_id>
  </id_info>
  <brief_title>The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones</brief_title>
  <official_title>The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones. A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating&#xD;
      bidirectional approach versus the standard approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shock wave lithotripsy (SWL) has been considered the preferred method for treating upper&#xD;
      urinary tract stones since 1980s due to its minimally invasive characters and low morbidity.&#xD;
      The overall stone free rates have been reported to be 80% to 90% .&#xD;
&#xD;
      In the presence of pregnancy, untreated urinary tract infection, decompensated coagulopathy,&#xD;
      uncontrolled arrhythmia and abdominal aortic aneurysm, other treatment methods should be&#xD;
      considered .&#xD;
&#xD;
      SWL is associated with some complications. The most common complications of SWL are renal&#xD;
      colic (40%), gross hematuria (32%), urinary obstruction (30.9%), symptomatic bacteriuria&#xD;
      (9.7%) and perirenal hematoma or subclinical subcapsular hematoma (4.6%).&#xD;
&#xD;
      There are many factors affecting the success of SWL as patient age, sex, body mass index&#xD;
      (BMI), stone size, site and number, radiological renal features, congenital renal anomalies&#xD;
      and presence of double-J (DJ) ureteric stent .&#xD;
&#xD;
      Regarding the renal stones, stones smaller than 10 mm had a success rate of 90%, while those&#xD;
      larger than 10 mm had a success rate of 70%. Stones located in the renal pelvis and upper&#xD;
      pole had a success rate of 87.3 and 88.5% respectively, while those located in the lower pole&#xD;
      had a success rate of 69.5%. A single renal stone had a 78.3% success rate compared to 62.8%&#xD;
      in multiple renal stones . Regarding the ureteric stones, stone size more than 10 mm was one&#xD;
      of the strongest independent predictors of failure of SWL&#xD;
&#xD;
      Patients appear to have the best chance for successful SWL when they have small BMI and their&#xD;
      stones are single and located in the renal pelvis . Skin to stone distance (SSD) measured by&#xD;
      non-contrast computerized tomography scan (NCCT) has a significant role in the treatment of&#xD;
      renal stones using SWL. Slow shock wave rate (60/min) is associated with increase in the&#xD;
      success rate and decrease in pain, complication and number of session to achieve success when&#xD;
      compared to rapid shock wave rate (120/min)&#xD;
&#xD;
      Some techniques were developed to increase the efficacy of SWL. In 1999, the bidirectional&#xD;
      synchronous twin-pulse technique with variable angles between the shock wave reflectors was&#xD;
      developed and it improved the quality and rate of stone disintegration in vitro and it was&#xD;
      more effective than the traditional single generator and also it decreases the overall&#xD;
      treatment times&#xD;
&#xD;
      The TWINHEADS 101 lithotripter comprises two identical under and over table reflectors to&#xD;
      permit synchronous shock waves emission from two perpendicular directions to the same focal&#xD;
      point. This technique intensifies and localizes the cavitations effects by the interacting&#xD;
      focal zones of both reflectors, resulting in a better quality and rate of stone&#xD;
      disintegration, especially with a right angle between the axes of the reflectors.&#xD;
&#xD;
      The first prospective clinical study was done in 2005 regarding synchronous twin-pulse SWL&#xD;
      and it seems safe and effective for treating patients with renal and upper ureteric stones.&#xD;
      The stone-free rate was 74% after one session and 100% after two sessions within a month&#xD;
&#xD;
      Based on the principle of the TWINHEADS lithotripter, we will use Dornier Gemini lithotripter&#xD;
      to emit the shock waves from two different directions to the same focal point asynchronously&#xD;
      for renal and upper lumbar ureteric stones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Anticipated">March 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stone free rate three months after the last session</measure>
    <time_frame>18 months</time_frame>
    <description>residual less than 4 mm by non-contrast computerized tomography scan (NCCT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>severity of complications after SWL in both groups</measure>
    <time_frame>18 months</time_frame>
    <description>Clavien-Dindo scale of surgical complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Urologic Diseases</condition>
  <condition>Stones, Kidney</condition>
  <condition>Stone, Urinary</condition>
  <condition>Shock Wave Lithotripsy</condition>
  <arm_group>
    <arm_group_label>Bidirectional Shock Wave Lithotripsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>alternating bidirectional (under and over table) approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Shock Wave Lithotripsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard unidirectional approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bidirectional Shock Wave Lithotripsy</intervention_name>
    <description>the alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones</description>
    <arm_group_label>Bidirectional Shock Wave Lithotripsy</arm_group_label>
    <other_name>Bidirectional SWL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Shock Wave Lithotripsy</intervention_name>
    <description>the standard unidirectional approach during SWL for renal and upper lumbar ureteric stones</description>
    <arm_group_label>Standard Shock Wave Lithotripsy</arm_group_label>
    <other_name>Standard SWL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient criteria:&#xD;
&#xD;
               1. Ability to give informed consent.&#xD;
&#xD;
               2. Normal laboratory profile as regarding serum creatinine, liver function,&#xD;
                  platelets count and prothrombin time.&#xD;
&#xD;
          -  Stone criteria:&#xD;
&#xD;
               1. Single renal stone less than two cm or upper lumbar ureteric stone less than one&#xD;
                  cm.&#xD;
&#xD;
               2. Radio-opaque stones.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bleeding tendency.&#xD;
&#xD;
          2. Poor kidney function.&#xD;
&#xD;
          3. Pregnancy.&#xD;
&#xD;
          4. Abdominal aortic aneurysm.&#xD;
&#xD;
          5. Indwelling DJ ureteric stent or percutaneous nephrostomy tube (PCN).&#xD;
&#xD;
          6. Congenital anomalies of the urinary tract.&#xD;
&#xD;
          7. Untreated urinary tract infection.&#xD;
&#xD;
          8. Obstructed urinary tract distal to the stone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Urology and Nephrology center</name>
      <address>
        <city>Mansoura</city>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mahamed Hegazy</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Shock wave lithotripsy</keyword>
  <keyword>Bidirectional</keyword>
  <keyword>Stones</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urologic Diseases</mesh_term>
    <mesh_term>Ureteral Calculi</mesh_term>
    <mesh_term>Ureterolithiasis</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Shock</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <!-- 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/NCT03243682
org study id: Bidirectional SWL
nct id: NCT03243682
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating
      bidirectional approach versus the standard approach.
Shock wave lithotripsy (SWL) has been considered the preferred method for treating upper
      urinary tract stones since 1980s due to its minimally invasive characters and low morbidity.
      The overall stone free rates have been reported to be 80% to 90% .

      In the presence of pregnancy, untreated urinary tract infection, decompensated coagulopathy,
      uncontrolled arrhythmia and abdominal aortic aneurysm, other treatment methods should be
      considered .

      SWL is associated with some complications. The most common complications of SWL are renal
      colic (40%), gross hematuria (32%), urinary obstruction (30.9%), symptomatic bacteriuria
      (9.7%) and perirenal hematoma or subclinical subcapsular hematoma (4.6%).

      There are many factors affecting the success of SWL as patient age, sex, body mass index
      (BMI), stone size, site and number, radiological renal features, congenital renal anomalies
      and presence of double-J (DJ) ureteric stent .

      Regarding the renal stones, stones smaller than 10 mm had a success rate of 90%, while those
      larger than 10 mm had a success rate of 70%. Stones located in the renal pelvis and upper
      pole had a success rate of 87.3 and 88.5% respectively, while those located in the lower pole
      had a success rate of 69.5%. A single renal stone had a 78.3% success rate compared to 62.8%
      in multiple renal stones . Regarding the ureteric stones, stone size more than 10 mm was one
      of the strongest independent predictors of failure of SWL

      Patients appear to have the best chance for successful SWL when they have small BMI and their
      stones are single and located in the renal pelvis . Skin to stone distance (SSD) measured by
      non-contrast computerized tomography scan (NCCT) has a significant role in the treatment of
      renal stones using SWL. Slow shock wave rate (60/min) is associated with increase in the
      success rate and decrease in pain, complication and number of session to achieve success when
      compared to rapid shock wave rate (120/min)

      Some techniques were developed to increase the efficacy of SWL. In 1999, the bidirectional
      synchronous twin-pulse technique with variable angles between the shock wave reflectors was
      developed and it improved the quality and rate of stone disintegration in vitro and it was
      more effective than the traditional single generator and also it decreases the overall
      treatment times

      The TWINHEADS 101 lithotripter comprises two identical under and over table reflectors to
      permit synchronous shock waves emission from two perpendicular directions to the same focal
      point. This technique intensifies and localizes the cavitations effects by the interacting
      focal zones of both reflectors, resulting in a better quality and rate of stone
      disintegration, especially with a right angle between the axes of the reflectors.

      The first prospective clinical study was done in 2005 regarding synchronous twin-pulse SWL
      and it seems safe and effective for treating patients with renal and upper ureteric stones.
      The stone-free rate was 74% after one session and 100% after two sessions within a month

      Based on the principle of the TWINHEADS lithotripter, we will use Dornier Gemini lithotripter
      to emit the shock waves from two different directions to the same focal point asynchronously
      for renal and upper lumbar ureteric stones.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: stone free rate three months after the last session
time frame: 18 months
description: residual less than 4 mm by non-contrast computerized tomography scan (NCCT)
measure: severity of complications after SWL in both groups
time frame: 18 months
description: Clavien-Dindo scale of surgical complications
arm group label: Bidirectional Shock Wave Lithotripsy
arm group type: Active Comparator
description: alternating bidirectional (under and over table) approach
arm group label: Standard Shock Wave Lithotripsy
arm group type: Active Comparator
description: standard unidirectional approach
intervention type: Procedure
intervention name: Bidirectional Shock Wave Lithotripsy
description: the alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones
arm group label: Bidirectional Shock Wave Lithotripsy
other name: Bidirectional SWL
intervention type: Procedure
intervention name: Standard Shock Wave Lithotripsy
description: the standard unidirectional approach during SWL for renal and upper lumbar ureteric stones
arm group label: Standard Shock Wave Lithotripsy
other name: Standard SWL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mahamed Hegazy
investigator title: MD
mesh term: Urologic Diseases
mesh term: Ureteral Calculi
mesh term: Ureterolithiasis
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Urinary Calculi
mesh term: Shock
mesh term: Calculi