<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/NCT03274700</url>
  </required_header>
  <id_info>
    <org_study_id>tamsulosin in ureteric stones</org_study_id>
    <nct_id>NCT03274700</nct_id>
  </id_info>
  <brief_title>The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms</brief_title>
  <official_title>The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms: A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To estimate the efficacy of tamsulosin in:&#xD;
&#xD;
      A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).&#xD;
&#xD;
      B - Pain relief and hyronephrosis improvement (secondary goal).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urolithiasis affects 4-15% of world population and the incidence of this disease is&#xD;
      increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of&#xD;
      these ureteral stones are found in the distal part of the ureters . The goal of treatment of&#xD;
      patients suffering from ureteral calculi is to achieve complete stone clearance with minimal&#xD;
      morbidity .&#xD;
&#xD;
      Ureteral calculi of any size may be associated with renal obstruction and care must be taken&#xD;
      to prevent irreversible damage to kidney, whether patient selects expectant or active&#xD;
      treatment . An expectant treatment or watchful waiting approach may be expected to produce&#xD;
      spontaneous stone expulsion up to 50% of cases but some complications such as urinary&#xD;
      infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative&#xD;
      approach proves to be unsuccessful, interventional treatment becomes necessary. After a&#xD;
      period of conservative treatment, however, intervention is often inefficient or has a higher&#xD;
      risk for complications due to stone impaction and the associated inflammatory reaction of the&#xD;
      ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal&#xD;
      invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but&#xD;
      these procedures are not risk free and they require some experience and not cost effective .&#xD;
&#xD;
      The therapeutic potential of α-blockers for ureteral stone disease has been investigated,&#xD;
      prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus&#xD;
      on tamsulosin because it is the most frequently studied α-blocker, recommended in urology&#xD;
      treatment guidelines, and, in our experience, the most common medical expulsive therapy used&#xD;
      by emergency physicians .&#xD;
&#xD;
      The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral&#xD;
      stones from 10-15 mm diameter in a randomised, placebo-controlled setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Early Phase 1</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.</measure>
    <time_frame>1year</time_frame>
    <description>Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:&#xD;
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.&#xD;
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.&#xD;
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Ureteric Stone</condition>
  <arm_group>
    <arm_group_label>Group 1: Patients receive tamsulosin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:&#xD;
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.&#xD;
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.&#xD;
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients receive placebo.</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following:&#xD;
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.&#xD;
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.&#xD;
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin.</intervention_name>
    <description>Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.</description>
    <arm_group_label>Group 1: Patients receive tamsulosin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo.</intervention_name>
    <description>Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.</description>
    <arm_group_label>Patients receive placebo.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Lower ureteric stones from(10-15) mm diameters.&#xD;
&#xD;
          2. Age group equal or more than 18 years.&#xD;
&#xD;
          3. Normal renal function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lower ureteric stones less than 10mm and more than 15 mm diameters.&#xD;
&#xD;
          2. Age group less than 18 years.&#xD;
&#xD;
          3. Associated ureteric strictures.&#xD;
&#xD;
          4. Febrile urinary tract infections.&#xD;
&#xD;
          5. Severe hydronephrosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>mahmoud eldardery, resident</last_name>
    <phone>01008763519</phone>
    <email>meldardery91@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ahmed elderwy, professor</last_name>
    <phone>01063544453</phone>
    <email>ahmad.elderwy@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Pearle MS. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. Int Braz J Urol. 2004 Nov-Dec;30(6):546-547. No abstract available.</citation>
    <PMID>15748331</PMID>
  </reference>
  <reference>
    <citation>Wang RC, Smith-Bindman R, Whitaker E, Neilson J, Allen IE, Stoller ML, Fahimi J. Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis. Ann Emerg Med. 2017 Mar;69(3):353-361.e3. doi: 10.1016/j.annemergmed.2016.06.044. Epub 2016 Sep 8.</citation>
    <PMID>27616037</PMID>
  </reference>
  <reference>
    <citation>Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H. The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones. J Urol. 2005 Jun;173(6):2010-2. doi: 10.1097/01.ju.0000158453.60029.0a.</citation>
    <PMID>15879806</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mahmoud eldardery</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ureteral Calculi</mesh_term>
    <mesh_term>Ureterolithiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_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/NCT03274700
org study id: tamsulosin in ureteric stones
nct id: NCT03274700
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To estimate the efficacy of tamsulosin in:

      A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).

      B - Pain relief and hyronephrosis improvement (secondary goal).
Urolithiasis affects 4-15% of world population and the incidence of this disease is
      increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of
      these ureteral stones are found in the distal part of the ureters . The goal of treatment of
      patients suffering from ureteral calculi is to achieve complete stone clearance with minimal
      morbidity .

      Ureteral calculi of any size may be associated with renal obstruction and care must be taken
      to prevent irreversible damage to kidney, whether patient selects expectant or active
      treatment . An expectant treatment or watchful waiting approach may be expected to produce
      spontaneous stone expulsion up to 50% of cases but some complications such as urinary
      infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative
      approach proves to be unsuccessful, interventional treatment becomes necessary. After a
      period of conservative treatment, however, intervention is often inefficient or has a higher
      risk for complications due to stone impaction and the associated inflammatory reaction of the
      ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal
      invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but
      these procedures are not risk free and they require some experience and not cost effective .

      The therapeutic potential of α-blockers for ureteral stone disease has been investigated,
      prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus
      on tamsulosin because it is the most frequently studied α-blocker, recommended in urology
      treatment guidelines, and, in our experience, the most common medical expulsive therapy used
      by emergency physicians .

      The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral
      stones from 10-15 mm diameter in a randomised, placebo-controlled setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.
time frame: 1year
description: Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
arm group label: Group 1: Patients receive tamsulosin
arm group type: Active Comparator
description: Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing:
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
arm group label: Patients receive placebo.
arm group type: Placebo Comparator
description: Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following:
In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.
At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.
At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
intervention type: Drug
intervention name: Tamsulosin.
description: Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
arm group label: Group 1: Patients receive tamsulosin
intervention type: Drug
intervention name: Placebo.
description: Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
arm group label: Patients receive placebo.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mahmoud eldardery, resident
phone: 01008763519
email: meldardery91@gmail.com
last name: ahmed elderwy, professor
phone: 01063544453
email: ahmad.elderwy@gmail.com
citation: Pearle MS. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. Int Braz J Urol. 2004 Nov-Dec;30(6):546-547. No abstract available.
PMID: 15748331
citation: Wang RC, Smith-Bindman R, Whitaker E, Neilson J, Allen IE, Stoller ML, Fahimi J. Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis. Ann Emerg Med. 2017 Mar;69(3):353-361.e3. doi: 10.1016/j.annemergmed.2016.06.044. Epub 2016 Sep 8.
PMID: 27616037
citation: Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H. The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones. J Urol. 2005 Jun;173(6):2010-2. doi: 10.1097/01.ju.0000158453.60029.0a.
PMID: 15879806
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mahmoud eldardery
investigator title: resident
mesh term: Ureteral Calculi
mesh term: Ureterolithiasis
mesh term: Tamsulosin