<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/NCT03799120</url>
  </required_header>
  <id_info>
    <org_study_id>2-18-11-001</org_study_id>
    <nct_id>NCT03799120</nct_id>
  </id_info>
  <brief_title>Daily Versus Twice Per Day Tamsulosin for Ureteral Stent Symptoms</brief_title>
  <official_title>The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gundersen Lutheran Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gundersen Lutheran Medical Foundation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg&#xD;
      QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ureteral stents are commonly used to maintain patency of the ureter and are placed for&#xD;
      several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or&#xD;
      fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses&#xD;
      or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been&#xD;
      associated with significant discomfort and dissatisfaction among patients.5 Bosio and&#xD;
      colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary&#xD;
      frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported&#xD;
      urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the&#xD;
      kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over&#xD;
      90% of patients reported that this pain interfered with their everyday life.&#xD;
&#xD;
      The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues&#xD;
      to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures&#xD;
      several domains relating to stent pain including general health, urinary issues, pain, work&#xD;
      performance, sexual matters, and quality of life with stent in situ. The USSQ has been&#xD;
      validated and translated and is currently a widely used measure.&#xD;
&#xD;
      While commonly used for treatment of benign prostatic hyperplasia, several studies have&#xD;
      evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant&#xD;
      improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores&#xD;
      and 7.2 in body pain scores). To date, randomized controlled trials have used one of two&#xD;
      types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic&#xD;
      hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg&#xD;
      daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase&#xD;
      in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for&#xD;
      lower urinary tract symptoms for patients with an indwelling stent. No study to date,&#xD;
      however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on&#xD;
      stent-related symptoms. The objective of this study is to assess two different dosing&#xD;
      regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ureteric Stent Symptoms Questionnaire</measure>
    <time_frame>1 week post-stent placement</time_frame>
    <description>Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Ureteral Diseases</condition>
  <arm_group>
    <arm_group_label>tamsulosin QD + Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.4 mg tamsulosin QD + Placebo QD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tamsulosin BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.4 mg tamsulosin BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin BID</intervention_name>
    <description>comparison of once daily versus twice daily tamsulosin</description>
    <arm_group_label>tamsulosin BID</arm_group_label>
    <arm_group_label>tamsulosin QD + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>tamsulosin QD + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 18 and 70 years old.&#xD;
&#xD;
          -  Planning to undergo ureteroscopy with ureteral stent placement at our site.&#xD;
&#xD;
          -  Able to read and understand an English language survey (USSQ).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are unable to provide informed consent.&#xD;
&#xD;
          2. Patients who are already taking an alpha-blocker.&#xD;
&#xD;
          3. Patients with hypersensitivity or known adverse side effects of tamsulosin or its&#xD;
             ingredients and those who are not candidates for tamsulosin per attending Urologist&#xD;
             discretion.&#xD;
&#xD;
          4. Patients with a preexisting bladder condition including UTI within 30 days of the&#xD;
             procedure.&#xD;
&#xD;
          5. Patients with hepatitis C on boceprevir.&#xD;
&#xD;
          6. Patients who have medical conditions known to be associated with chronic pain, those&#xD;
             taking medications for chronic pain such as gabapentin or a chronic opioid per the&#xD;
             judgement of the PI, or those with a pain contract on file.&#xD;
&#xD;
          7. Women who are pregnant or planning to become pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Ferroni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gundersen Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gundersen Health System</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.</citation>
    <PMID>27125392</PMID>
  </reference>
  <reference>
    <citation>Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19.</citation>
    <PMID>29923014</PMID>
  </reference>
  <reference>
    <citation>Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.</citation>
    <PMID>12576846</PMID>
  </reference>
  <reference>
    <citation>Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.</citation>
    <PMID>21453351</PMID>
  </reference>
  <reference>
    <citation>Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.</citation>
    <PMID>27809592</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>February 22, 2019</last_update_submitted>
  <last_update_submitted_qc>February 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gundersen Lutheran Medical Foundation</investigator_affiliation>
    <investigator_full_name>Kara Kallies</investigator_full_name>
    <investigator_title>Academic Researcher / study coordinator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ureteral Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03799120
org study id: 2-18-11-001
nct id: NCT03799120
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg
      QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.
Ureteral stents are commonly used to maintain patency of the ureter and are placed for
      several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or
      fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses
      or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been
      associated with significant discomfort and dissatisfaction among patients.5 Bosio and
      colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary
      frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported
      urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the
      kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over
      90% of patients reported that this pain interfered with their everyday life.

      The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues
      to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures
      several domains relating to stent pain including general health, urinary issues, pain, work
      performance, sexual matters, and quality of life with stent in situ. The USSQ has been
      validated and translated and is currently a widely used measure.

      While commonly used for treatment of benign prostatic hyperplasia, several studies have
      evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant
      improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores
      and 7.2 in body pain scores). To date, randomized controlled trials have used one of two
      types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic
      hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg
      daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase
      in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for
      lower urinary tract symptoms for patients with an indwelling stent. No study to date,
      however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on
      stent-related symptoms. The objective of this study is to assess two different dosing
      regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Ureteric Stent Symptoms Questionnaire
time frame: 1 week post-stent placement
description: Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.
arm group label: tamsulosin QD + Placebo
arm group type: Placebo Comparator
description: 0.4 mg tamsulosin QD + Placebo QD
arm group label: tamsulosin BID
arm group type: Experimental
description: 0.4 mg tamsulosin BID
intervention type: Drug
intervention name: Tamsulosin BID
description: comparison of once daily versus twice daily tamsulosin
arm group label: tamsulosin BID
arm group label: tamsulosin QD + Placebo
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: tamsulosin QD + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Matthew Ferroni, MD
role: Principal Investigator
affiliation: Gundersen Health System
facility: 
country: United States
citation: Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.
PMID: 27125392
citation: Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19.
PMID: 29923014
citation: Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.
PMID: 12576846
citation: Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.
PMID: 21453351
citation: Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.
PMID: 27809592
responsible party type: Principal Investigator
investigator affiliation: Gundersen Lutheran Medical Foundation
investigator full name: Kara Kallies
investigator title: Academic Researcher / study coordinator
mesh term: Ureteral Diseases
mesh term: Tamsulosin
sharing ipd: No