<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/NCT03266770</url>
  </required_header>
  <id_info>
    <org_study_id>04-17-30</org_study_id>
    <nct_id>NCT03266770</nct_id>
  </id_info>
  <brief_title>The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position</brief_title>
  <official_title>The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditional ureteral stents are commonly used in renal and ureteral procedures, and their use&#xD;
      is associated with many morbidities which can affect patients' quality of life. However,&#xD;
      replacement of the distal portion of the stent with a thin material may reduce bladder&#xD;
      irritative symptoms and allow the ureterovesical junction to coapt---thereby, reducing&#xD;
      urinary reflux. The hypothesis is that the RELIEF stent will offer the same function of&#xD;
      traditional ureteral stents with the added benefits of minimizing urinary reflux and reducing&#xD;
      irritative bladder symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditional ureteral stents are commonly used in practice to relieve renal obstruction or as&#xD;
      a scaffold to promote healing after endoscopic or open/ laparoscopic surgeries involving the&#xD;
      ureter. However, there are many morbidities associated with stent placement either due to&#xD;
      bladder irritation or backflow of urine to the kidney. The most commonly reported symptoms&#xD;
      include urgency, urinary frequency, dysuria, incontinence, hematuria, suprapubic discomfort,&#xD;
      and fever due to urinary tract infections and flank pain, which can occur in up to 80% of&#xD;
      stented patients. Sometimes, the symptoms are poorly tolerated and can negatively affect&#xD;
      patients' quality of life. Shao et al have studied the relationship between bladder filling&#xD;
      and the renal pelvic pressure (RPP) in stented patients, which revealed that RPP increased&#xD;
      mildly during bladder filling and increased dramatically during voiding, indicating urinary&#xD;
      reflux, and thus encouraging early stent removal. Another study showed that patients with&#xD;
      stents whose distal coils cross the midline are at higher risk of post-stenting morbidities.&#xD;
      Replacement of the distal portion of the ureteral stent with a thin material may reduce&#xD;
      bladder irritative symptoms and allow the ureterovesical junction to coapt, thereby&#xD;
      eliminating urinary reflux.&#xD;
&#xD;
      The Ureteral Stent Company, LLC (USC) is developing the RELIEF™ Ureteral Stent, a single use,&#xD;
      disposable ureteral stent (US) device that will provide the traditional function of allowing&#xD;
      the passage of urine from the kidney to the bladder with new design enhancements to improve&#xD;
      patient care:&#xD;
&#xD;
        -  A low-profile tether through the intramural ureter segment, minimizing the potential of&#xD;
           urinary reflux&#xD;
&#xD;
        -  Polymeric solid distal coil that minimizes the potential for coil positioning on the&#xD;
           trigone, reducing the potential for associated bladder spasms and pain.&#xD;
&#xD;
      It is hypothesized that the RELIEF stent will offer the same function of traditional ureteral&#xD;
      stents with the added benefits of minimizing the urinary reflux and reducing irritative&#xD;
      bladder symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2021</start_date>
  <completion_date type="Actual">December 12, 2022</completion_date>
  <primary_completion_date type="Actual">December 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of bladder irritation symptoms (e.g. frequency, urgency, nocturia, urine leakage...) associated with the RELIEF Stent.</measure>
    <time_frame>0-30 days.</time_frame>
    <description>Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate bladder irritation symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in loin pain scores from baseline</measure>
    <time_frame>At 30 days.</time_frame>
    <description>The 1-10 Visual Analog Scale part of the Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate the change of loin pain from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of RELIEF Stent-Related Adverse Events</measure>
    <time_frame>0-30 days.</time_frame>
    <description>Assessment of adverse events (incidence, relationship to device, severity) attributed to the RELIEF stent compared to established adverse event rates from published clinical studies and FDA reported events of conventional ureteral stents.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Ureteral Obstruction</condition>
  <arm_group>
    <arm_group_label>RELIEF stent placement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After meeting the inclusion criteria and being consented, patients will have the RELIEF stent inserted in the ureter during cystoscopy per standard of care for ureteral stent placement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RELIEF Stent</intervention_name>
    <description>The RELIEF stent will be placed under cystoscopy. The stent with pusher will be placed over the guidewire and inserted. The pusher will be positioned, the guidewire will be removed, and the pusher will be retracted. The position of the stent will be confirmed by x-ray (C-arm).</description>
    <arm_group_label>RELIEF stent placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ureteral stone of 5-25 mm measured on plain abdomen X-ray KUB (Kidney Ureter Bladder)&#xD;
             or CT (computed tomography).&#xD;
&#xD;
          -  Upper or middle third ureteral stricture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with distal ureteral obstruction&#xD;
&#xD;
          -  Patients with urinary reflux&#xD;
&#xD;
          -  Patients requiring bilateral surgical stone management procedure&#xD;
&#xD;
          -  Intraoperative exclusion: Based on the urologist's discretion, if trauma has been&#xD;
             induced to the distal ureter due to ureteroscopy maneuvers, these patients will be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyle Scarberry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chew BH, Knudsen BE, Denstedt JD. The use of stents in contemporary urology. Curr Opin Urol. 2004 Mar;14(2):111-5. doi: 10.1097/00042307-200403000-00011.</citation>
    <PMID>15075840</PMID>
  </reference>
  <reference>
    <citation>Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-6. doi: 10.1016/s0090-4295(01)01644-2.</citation>
    <PMID>11927301</PMID>
  </reference>
  <reference>
    <citation>Chambade D, Thibault F, Niang L, Lakmichi MA, Gattegno B, Thibault P, Traxer O. [Study of the safety of double J ureteric stents]. Prog Urol. 2006 Sep;16(4):445-9. French.</citation>
    <PMID>17069037</PMID>
  </reference>
  <reference>
    <citation>Shao Y, Shen ZJ, Zhuo J, Liu HT, Yu SQ, Xia SJ. The influence of ureteral stent on renal pelvic pressure in vivo. Urol Res. 2009 Aug;37(4):221-5. doi: 10.1007/s00240-009-0199-z. Epub 2009 Jun 10.</citation>
    <PMID>19513705</PMID>
  </reference>
  <reference>
    <citation>Giannarini G, Keeley FX Jr, Valent F, Manassero F, Mogorovich A, Autorino R, Selli C. Predictors of morbidity in patients with indwelling ureteric stents: results of a prospective study using the validated Ureteric Stent Symptoms Questionnaire. BJU Int. 2011 Feb;107(4):648-54. doi: 10.1111/j.1464-410X.2010.09482.x.</citation>
    <PMID>20590539</PMID>
  </reference>
  <reference>
    <citation>Krebs A, Deane LA, Borin JF, Edwards RA, Sala LG, Khan F, Abdelshehid C, McDougall EM, Clayman RV. The 'buoy' stent: evaluation of a prototype indwelling ureteric stent in a porcine model. BJU Int. 2009 Jul;104(1):88-92. doi: 10.1111/j.1464-410X.2008.08338.x. Epub 2009 Jan 14.</citation>
    <PMID>19154469</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>December 30, 2022</last_update_submitted>
  <last_update_submitted_qc>December 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Kyle Scarberry, MD</investigator_full_name>
    <investigator_title>Assistant Professor, Urology</investigator_title>
  </responsible_party>
  <keyword>ureteral stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ureteral Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers</ipd_description>
  </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/NCT03266770
org study id: 04-17-30
nct id: NCT03266770
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Traditional ureteral stents are commonly used in renal and ureteral procedures, and their use
      is associated with many morbidities which can affect patients' quality of life. However,
      replacement of the distal portion of the stent with a thin material may reduce bladder
      irritative symptoms and allow the ureterovesical junction to coapt---thereby, reducing
      urinary reflux. The hypothesis is that the RELIEF stent will offer the same function of
      traditional ureteral stents with the added benefits of minimizing urinary reflux and reducing
      irritative bladder symptoms.
Traditional ureteral stents are commonly used in practice to relieve renal obstruction or as
      a scaffold to promote healing after endoscopic or open/ laparoscopic surgeries involving the
      ureter. However, there are many morbidities associated with stent placement either due to
      bladder irritation or backflow of urine to the kidney. The most commonly reported symptoms
      include urgency, urinary frequency, dysuria, incontinence, hematuria, suprapubic discomfort,
      and fever due to urinary tract infections and flank pain, which can occur in up to 80% of
      stented patients. Sometimes, the symptoms are poorly tolerated and can negatively affect
      patients' quality of life. Shao et al have studied the relationship between bladder filling
      and the renal pelvic pressure (RPP) in stented patients, which revealed that RPP increased
      mildly during bladder filling and increased dramatically during voiding, indicating urinary
      reflux, and thus encouraging early stent removal. Another study showed that patients with
      stents whose distal coils cross the midline are at higher risk of post-stenting morbidities.
      Replacement of the distal portion of the ureteral stent with a thin material may reduce
      bladder irritative symptoms and allow the ureterovesical junction to coapt, thereby
      eliminating urinary reflux.

      The Ureteral Stent Company, LLC (USC) is developing the RELIEF™ Ureteral Stent, a single use,
      disposable ureteral stent (US) device that will provide the traditional function of allowing
      the passage of urine from the kidney to the bladder with new design enhancements to improve
      patient care:

        -  A low-profile tether through the intramural ureter segment, minimizing the potential of
           urinary reflux

        -  Polymeric solid distal coil that minimizes the potential for coil positioning on the
           trigone, reducing the potential for associated bladder spasms and pain.

      It is hypothesized that the RELIEF stent will offer the same function of traditional ureteral
      stents with the added benefits of minimizing the urinary reflux and reducing irritative
      bladder symptoms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of bladder irritation symptoms (e.g. frequency, urgency, nocturia, urine leakage...) associated with the RELIEF Stent.
time frame: 0-30 days.
description: Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate bladder irritation symptoms.
measure: Change in loin pain scores from baseline
time frame: At 30 days.
description: The 1-10 Visual Analog Scale part of the Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate the change of loin pain from baseline.
measure: Incidence of RELIEF Stent-Related Adverse Events
time frame: 0-30 days.
description: Assessment of adverse events (incidence, relationship to device, severity) attributed to the RELIEF stent compared to established adverse event rates from published clinical studies and FDA reported events of conventional ureteral stents.
arm group label: RELIEF stent placement
arm group type: Other
description: After meeting the inclusion criteria and being consented, patients will have the RELIEF stent inserted in the ureter during cystoscopy per standard of care for ureteral stent placement.
intervention type: Device
intervention name: RELIEF Stent
description: The RELIEF stent will be placed under cystoscopy. The stent with pusher will be placed over the guidewire and inserted. The pusher will be positioned, the guidewire will be removed, and the pusher will be retracted. The position of the stent will be confirmed by x-ray (C-arm).
arm group label: RELIEF stent placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyle Scarberry, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
citation: Chew BH, Knudsen BE, Denstedt JD. The use of stents in contemporary urology. Curr Opin Urol. 2004 Mar;14(2):111-5. doi: 10.1097/00042307-200403000-00011.
PMID: 15075840
citation: Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-6. doi: 10.1016/s0090-4295(01)01644-2.
PMID: 11927301
citation: Chambade D, Thibault F, Niang L, Lakmichi MA, Gattegno B, Thibault P, Traxer O. [Study of the safety of double J ureteric stents]. Prog Urol. 2006 Sep;16(4):445-9. French.
PMID: 17069037
citation: Shao Y, Shen ZJ, Zhuo J, Liu HT, Yu SQ, Xia SJ. The influence of ureteral stent on renal pelvic pressure in vivo. Urol Res. 2009 Aug;37(4):221-5. doi: 10.1007/s00240-009-0199-z. Epub 2009 Jun 10.
PMID: 19513705
citation: Giannarini G, Keeley FX Jr, Valent F, Manassero F, Mogorovich A, Autorino R, Selli C. Predictors of morbidity in patients with indwelling ureteric stents: results of a prospective study using the validated Ureteric Stent Symptoms Questionnaire. BJU Int. 2011 Feb;107(4):648-54. doi: 10.1111/j.1464-410X.2010.09482.x.
PMID: 20590539
citation: Krebs A, Deane LA, Borin JF, Edwards RA, Sala LG, Khan F, Abdelshehid C, McDougall EM, Clayman RV. The 'buoy' stent: evaluation of a prototype indwelling ureteric stent in a porcine model. BJU Int. 2009 Jul;104(1):88-92. doi: 10.1111/j.1464-410X.2008.08338.x. Epub 2009 Jan 14.
PMID: 19154469
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Kyle Scarberry, MD
investigator title: Assistant Professor, Urology
mesh term: Ureteral Obstruction
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers