xml: <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/NCT05992363</url>
    </required_header>
    <id_info>
      <org_study_id>0100-23-RMC</org_study_id>
      <nct_id>NCT05992363</nct_id>
    </id_info>
    <brief_title>Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction</brief_title>
    <acronym>TSTENT</acronym>
    <official_title>Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rabin Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sheba Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rabin Medical Center</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>
        Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant&#xD;
        diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber&#xD;
        8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The&#xD;
        secondary endpoints are patient comfort, quality of life and overall survival.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant&#xD;
        diseases. MUO may induce renal failure, which would be a barrier to several therapies&#xD;
        including chemotherapy. Indwelling double-pigtail polymeric ureteral stent is a common method&#xD;
        to release renal obstruction, but does not necessarily guarantee renal decompression as most&#xD;
        studies reported stent failure with a mean of 30% at a mean time of three months [1-3].&#xD;
        Various endoscopic strategies have been proposed to increase time to failure, including&#xD;
        tandem polymeric stents, metallic spiral coil stent, self-expanding Nitinol stent and&#xD;
        polymeric stents with different lumen diameter and stiffness [4-7]. However, heterogeneity of&#xD;
        MUO, low number of patients, unspecified polymer type, retrospective studies and the lack of&#xD;
        a standard method to assess stent failure limit robust comparative analysis.&#xD;
  &#xD;
        Tandem ureteral stents (TUS) technique uses two polymeric ureteral stents passed&#xD;
        simultaneously to better withstand the presumed compressive forces that overcome conventional&#xD;
        single stent. This method offers an additional parallel lumen and allows more extraluminal&#xD;
        flow between the two stents [6].&#xD;
  &#xD;
        In a study on TUS in 39 renal units with MUO, two 6 Fr stents were inserted. Stent failure,&#xD;
        defined by flank pain with increasing creatinine level or worsening hydronephrosis during 3&#xD;
        months after stents insertion, was occurred in 4% of cases [7]. This low failure rate&#xD;
        compares favorably with the reported rates with single 6Fr polymeric stent or metallic stent.&#xD;
        However, stents irritation, defined by profound lower urinary tract symptoms or renal colic&#xD;
        in the absence of worsening hydronephrosis or infection, was reported in 29-85% of patients&#xD;
        [7,8].&#xD;
  &#xD;
        Silicon stent, which is considered biocompatible and soft, has the potential to be less&#xD;
        irritative. In a recent systematic review, silicone stents has less stent-related symptoms in&#xD;
        comparison to non-silicone polymers and ''hard'' stents. [9]. However, silicone has high&#xD;
        susceptibility to compression, which in case of MUO may results in lower drainage efficacy.&#xD;
  &#xD;
        This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone&#xD;
        stent in patients with MUO. The primary endpoint is stent failure rate. The secondary&#xD;
        endpoints are patient comfort, quality of life and overall survival.&#xD;
  &#xD;
        References:&#xD;
  &#xD;
          1. Docimo SG, Dewolf WC. High failure rate of indwelling ureteral stents in patients with&#xD;
             extrinsic obstruction: experience at 2 institutions. J Urol. 1989;142(2 Pt 1):277-279.&#xD;
             doi:10.1016/s0022-5347(17)38729-3&#xD;
  &#xD;
          2. Vogt B, Blanchet LH. Analysis of Ureteral Tumour Stents for Malignant Ureteral&#xD;
             Obstruction: Towards Reshaping an Optimal Stent. Res Rep Urol. 2021;13:773-782.&#xD;
             Published 2021 Oct 27. doi:10.2147/RRU.S334277&#xD;
  &#xD;
          3. Chung SY, Stein RJ, Landsittel D, et al. 15-year experience with the management of&#xD;
             extrinsic ureteral obstruction with indwelling ureteral stents. J Urol.&#xD;
             2004;172(2):592-595. doi:10.1097/01.ju.0000130510.28768.f5&#xD;
  &#xD;
          4. Patel C, Loughran D, Jones R, Abdulmajed M, Shergill I. The resonance® metallic ureteric&#xD;
             stent in the treatment of chronic ureteric obstruction: a safety and efficacy analysis&#xD;
             from a contemporary clinical series. BMC Urol. 2017;17(1):16. Published 2017 Mar 10.&#xD;
             doi:10.1186/s12894-017-0204-8&#xD;
  &#xD;
          5. Khoo CC, Ho C, Palaniappan V, et al. Single-Center Experience with Three Metallic&#xD;
             Ureteral Stents (Allium® URS, Memokath™-051, and Resonance®) for Chronic Ureteral&#xD;
             Obstruction. J Endourol. 2021;35(12):1829-1837. doi:10.1089/end.2021.0208&#xD;
  &#xD;
          6. Fromer DL, Shabsigh A, Benson MC, Gupta M. Simultaneous multiple double pigtail stents&#xD;
             for malignant ureteral obstruction. Urology. 2002;59(4):594-596.&#xD;
             doi:10.1016/s0090-4295(01)01646-7&#xD;
  &#xD;
          7. Elsamra SE, Motato H, Moreira DM, et al. Tandem ureteral stents for the decompression of&#xD;
             malignant and benign obstructive uropathy. J Endourol. 2013;27(10):1297-1302.&#xD;
             doi:10.1089/end.2013.0281&#xD;
  &#xD;
          8. Shvero A, Haifler M, Mahmud H, Dotan Z, Winkler H, Kleinmann N. Quality of life with&#xD;
             tandem ureteral stents compared to percutaneous nephrostomy for malignant ureteral&#xD;
             obstruction. Support Care Cancer. 2022;30(11):9541-9548. doi:10.1007/s00520-022-07354-2&#xD;
  &#xD;
          9. Boeykens M, Keller EX, Bosio A, et al. Impact of Ureteral Stent Material on&#xD;
             Stent-related Symptoms: A Systematic Review of the Literature. Eur Urol Open Sci.&#xD;
             2022;45:108-117. Published 2022 Oct 19. doi:10.1016/j.euros.2022.09.005&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>stent failure rate</measure>
      <time_frame>1 year</time_frame>
      <description>Failure will be defined when two of the following three appear: renal colic, rise in serum creatinine, hydronephrosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>quality of life</measure>
      <time_frame>1 year</time_frame>
      <description>using the Ureteral stent symptom questionnaire (USSQ) score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall survival</measure>
      <time_frame>1 year</time_frame>
      <description>overall survival</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Hydronephrosis; Obstruction, Ureter</condition>
    <condition>Renal Failure</condition>
    <condition>Malignancy</condition>
    <condition>Ureter Obstruction</condition>
    <condition>Ureter Stricture</condition>
    <arm_group>
      <arm_group_label>single silicone stent</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tandem polyurethane stents</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ureteral stent\s insertion</intervention_name>
      <description>ureteral stent\s insertion in the operating room</description>
      <arm_group_label>Tandem polyurethane stents</arm_group_label>
      <arm_group_label>single silicone stent</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patient with malignant ureteral obstruction&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ureteral obstruction of other causes&#xD;
  &#xD;
            -  Language comprehension or other limitation in giving informed consent&#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>Rabin Medical Center</name>
        <address>
          <city>Petah Tikva</city>
          <zip>49414</zip>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Sheba medical center</name>
        <address>
          <city>Ramat Gan</city>
          <country>Israel</country>
        </address>
      </facility>
      <contact>
        <last_name>Ari Luder, MD</last_name>
        <phone>+972527812580</phone>
        <email>ariluder@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
      <investigator_full_name>Michael Frumer</investigator_full_name>
      <investigator_title>Urologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hydronephrosis</mesh_term>
      <mesh_term>Ureteral Obstruction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992363
  org study id: 0100-23-RMC
  nct id: NCT05992363
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant
        diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber
        8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The
        secondary endpoints are patient comfort, quality of life and overall survival.
  Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant
        diseases. MUO may induce renal failure, which would be a barrier to several therapies
        including chemotherapy. Indwelling double-pigtail polymeric ureteral stent is a common method
        to release renal obstruction, but does not necessarily guarantee renal decompression as most
        studies reported stent failure with a mean of 30% at a mean time of three months [1-3].
        Various endoscopic strategies have been proposed to increase time to failure, including
        tandem polymeric stents, metallic spiral coil stent, self-expanding Nitinol stent and
        polymeric stents with different lumen diameter and stiffness [4-7]. However, heterogeneity of
        MUO, low number of patients, unspecified polymer type, retrospective studies and the lack of
        a standard method to assess stent failure limit robust comparative analysis.
  
        Tandem ureteral stents (TUS) technique uses two polymeric ureteral stents passed
        simultaneously to better withstand the presumed compressive forces that overcome conventional
        single stent. This method offers an additional parallel lumen and allows more extraluminal
        flow between the two stents [6].
  
        In a study on TUS in 39 renal units with MUO, two 6 Fr stents were inserted. Stent failure,
        defined by flank pain with increasing creatinine level or worsening hydronephrosis during 3
        months after stents insertion, was occurred in 4% of cases [7]. This low failure rate
        compares favorably with the reported rates with single 6Fr polymeric stent or metallic stent.
        However, stents irritation, defined by profound lower urinary tract symptoms or renal colic
        in the absence of worsening hydronephrosis or infection, was reported in 29-85% of patients
        [7,8].
  
        Silicon stent, which is considered biocompatible and soft, has the potential to be less
        irritative. In a recent systematic review, silicone stents has less stent-related symptoms in
        comparison to non-silicone polymers and ''hard'' stents. [9]. However, silicone has high
        susceptibility to compression, which in case of MUO may results in lower drainage efficacy.
  
        This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone
        stent in patients with MUO. The primary endpoint is stent failure rate. The secondary
        endpoints are patient comfort, quality of life and overall survival.
  
        References:
  
          1. Docimo SG, Dewolf WC. High failure rate of indwelling ureteral stents in patients with
             extrinsic obstruction: experience at 2 institutions. J Urol. 1989;142(2 Pt 1):277-279.
             doi:10.1016/s0022-5347(17)38729-3
  
          2. Vogt B, Blanchet LH. Analysis of Ureteral Tumour Stents for Malignant Ureteral
             Obstruction: Towards Reshaping an Optimal Stent. Res Rep Urol. 2021;13:773-782.
             Published 2021 Oct 27. doi:10.2147/RRU.S334277
  
          3. Chung SY, Stein RJ, Landsittel D, et al. 15-year experience with the management of
             extrinsic ureteral obstruction with indwelling ureteral stents. J Urol.
             2004;172(2):592-595. doi:10.1097/01.ju.0000130510.28768.f5
  
          4. Patel C, Loughran D, Jones R, Abdulmajed M, Shergill I. The resonance® metallic ureteric
             stent in the treatment of chronic ureteric obstruction: a safety and efficacy analysis
             from a contemporary clinical series. BMC Urol. 2017;17(1):16. Published 2017 Mar 10.
             doi:10.1186/s12894-017-0204-8
  
          5. Khoo CC, Ho C, Palaniappan V, et al. Single-Center Experience with Three Metallic
             Ureteral Stents (Allium® URS, Memokath™-051, and Resonance®) for Chronic Ureteral
             Obstruction. J Endourol. 2021;35(12):1829-1837. doi:10.1089/end.2021.0208
  
          6. Fromer DL, Shabsigh A, Benson MC, Gupta M. Simultaneous multiple double pigtail stents
             for malignant ureteral obstruction. Urology. 2002;59(4):594-596.
             doi:10.1016/s0090-4295(01)01646-7
  
          7. Elsamra SE, Motato H, Moreira DM, et al. Tandem ureteral stents for the decompression of
             malignant and benign obstructive uropathy. J Endourol. 2013;27(10):1297-1302.
             doi:10.1089/end.2013.0281
  
          8. Shvero A, Haifler M, Mahmud H, Dotan Z, Winkler H, Kleinmann N. Quality of life with
             tandem ureteral stents compared to percutaneous nephrostomy for malignant ureteral
             obstruction. Support Care Cancer. 2022;30(11):9541-9548. doi:10.1007/s00520-022-07354-2
  
          9. Boeykens M, Keller EX, Bosio A, et al. Impact of Ureteral Stent Material on
             Stent-related Symptoms: A Systematic Review of the Literature. Eur Urol Open Sci.
             2022;45:108-117. Published 2022 Oct 19. doi:10.1016/j.euros.2022.09.005
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: stent failure rate
  time frame: 1 year
  description: Failure will be defined when two of the following three appear: renal colic, rise in serum creatinine, hydronephrosis
  measure: quality of life
  time frame: 1 year
  description: using the Ureteral stent symptom questionnaire (USSQ) score
  measure: overall survival
  time frame: 1 year
  description: overall survival
  arm group label: single silicone stent
  arm group type: Active Comparator
  description: patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent
  arm group label: Tandem polyurethane stents
  arm group type: Active Comparator
  description: patients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents
  intervention type: Device
  intervention name: ureteral stent\s insertion
  description: ureteral stent\s insertion in the operating room
  arm group label: Tandem polyurethane stents
  arm group label: single silicone stent
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  contact: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Rabin Medical Center
  investigator full name: Michael Frumer
  investigator title: Urologist
  mesh term: Hydronephrosis
  mesh term: Ureteral Obstruction
  sharing ipd: No