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Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) (BLUES)

Primary Purpose

Renal Stone, Ureteral Stone

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silicone (Coloplast Imajin Hydro) ureteral stent
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone focused on measuring Ureteral stent, Ureteroscopy, Lithotripsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study

  • Diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, Ultrasound or computerized tomography (CT) scan

    • Renal stone defined as only renal location of stone(s).
    • Ureteral stone defined as ureteral only or ureteral and renal stone(s).
  • Planned unilateral ureteroscopy with stent placement without stent string.
  • Ability to take oral medication.
  • Ability and willingness to complete and adhere to survey questions and responses throughout study duration.

Exclusion Criteria:

  • Known planned secondary or staged procedure
  • Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney)
  • Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder)
  • Presence of any indwelling ureteral stent prior to ureteroscopy
  • Presence of any indwelling nephrostomy tube prior to ureteroscopy
  • Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery
  • Renal stone located in calyceal diverticulum
  • No indication for stent placement (e.g. spontaneous passage)
  • Bladder stone location.
  • Pregnancy or lactation
  • Known allergic reactions to polyurethane or silicone

Sites / Locations

  • Michigan MedicineRecruiting
  • Michigan MedicineRecruiting
  • Chelsea Hospital (Saint Joseph Mercy)Recruiting
  • Henry Ford Macomb Hospital
  • Henry Ford HospitalRecruiting
  • Spectrum Health
  • Ascension Hospital (Comprehensive Urology)
  • William Beaumont Hospital (Michigan Institute of Urology)
  • William Beaumont Hospital (Michigan Institute of Urology)
  • Henry Ford West Bloomfield Hospital
  • Henry Ford Wyandotte Hospital
  • Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Silicone (Coloplast Imajin Hydro) ureteral stent

Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).

Arm Description

Outcomes

Primary Outcome Measures

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 7 to 10 days
This is a 3-item survey which participants select a response for intensity of their pain (no pain-very severe). Scores range from 36.3 - 81.8 with 81.8 being worse.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 7 to 10 days
This is a a 6-item survey in which participants respond how much pain interfered with their life (not at all- very much). Scores range from 41 - 78.3 with 78.3 being worse.

Secondary Outcome Measures

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 4 to 6 weeks
This is a 3-item survey which participants select a response for intensity of their pain (no pain-very severe). Scores range from 36.3 - 81.8 with 81.8 being worse.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 4 to 6 weeks
This is a a 6-item survey in which participants respond how much pain interfered with their life (not at all- very much). Scores range from 41 - 78.3 with 78.3 being worse.
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 scores at 7 to 10 days
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Scores ranging from 0 to 38 (higher scores = worse symptoms/bother).
Change in NIH LURN SI-10 scores at 4 to 6 weeks
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Scores ranging from 0 to 38 (higher scores = worse symptoms/bother).
Composite healthcare utilization metric within 30 days
Hospitalization and intensive care unit care Unplanned hospitalization Emergency department visit Ambulatory encounter: Clinic visit Ambulatory encounter: Phone call or message
Abnormal imaging findings within 60 days
New or worsening hydronephrosis, hematoma, and/or urinoma of the operative renal unit.
Stone-free rates within 60 days
No residual stone of the treated stone by postoperative imaging (CT, US, X-Ray, or any combination).

Full Information

First Posted
August 23, 2021
Last Updated
January 17, 2023
Sponsor
University of Michigan
Collaborators
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05026710
Brief Title
Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
Acronym
BLUES
Official Title
Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy. Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent. In addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery). The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone, Ureteral Stone
Keywords
Ureteral stent, Ureteroscopy, Lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silicone (Coloplast Imajin Hydro) ureteral stent
Arm Type
Experimental
Arm Title
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Silicone (Coloplast Imajin Hydro) ureteral stent
Intervention Description
During the end of the standard of care ureteroscopy the silicone stent will be placed.
Intervention Type
Device
Intervention Name(s)
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
Intervention Description
During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
Primary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 7 to 10 days
Description
This is a 3-item survey which participants select a response for intensity of their pain (no pain-very severe). Scores range from 36.3 - 81.8 with 81.8 being worse.
Time Frame
Baseline, 7 to 10 days
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 7 to 10 days
Description
This is a a 6-item survey in which participants respond how much pain interfered with their life (not at all- very much). Scores range from 41 - 78.3 with 78.3 being worse.
Time Frame
Baseline, 7 to 10 days
Secondary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 4 to 6 weeks
Description
This is a 3-item survey which participants select a response for intensity of their pain (no pain-very severe). Scores range from 36.3 - 81.8 with 81.8 being worse.
Time Frame
Baseline, 4 to 6 weeks
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 4 to 6 weeks
Description
This is a a 6-item survey in which participants respond how much pain interfered with their life (not at all- very much). Scores range from 41 - 78.3 with 78.3 being worse.
Time Frame
Baseline, 4 to 6 weeks
Title
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 scores at 7 to 10 days
Description
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Scores ranging from 0 to 38 (higher scores = worse symptoms/bother).
Time Frame
baseline, 7 to10 days
Title
Change in NIH LURN SI-10 scores at 4 to 6 weeks
Description
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Scores ranging from 0 to 38 (higher scores = worse symptoms/bother).
Time Frame
Baseline, 4 to 6 weeks
Title
Composite healthcare utilization metric within 30 days
Description
Hospitalization and intensive care unit care Unplanned hospitalization Emergency department visit Ambulatory encounter: Clinic visit Ambulatory encounter: Phone call or message
Time Frame
up to 30 days
Title
Abnormal imaging findings within 60 days
Description
New or worsening hydronephrosis, hematoma, and/or urinoma of the operative renal unit.
Time Frame
up to 60 days
Title
Stone-free rates within 60 days
Description
No residual stone of the treated stone by postoperative imaging (CT, US, X-Ray, or any combination).
Time Frame
up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stated willingness to comply with all study procedures and availability for the duration of the study Diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, Ultrasound or computerized tomography (CT) scan Renal stone defined as only renal location of stone(s). Ureteral stone defined as ureteral only or ureteral and renal stone(s). Planned unilateral ureteroscopy with stent placement without stent string. Ability to take oral medication. Ability and willingness to complete and adhere to survey questions and responses throughout study duration. Exclusion Criteria: Known planned secondary or staged procedure Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney) Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder) Presence of any indwelling ureteral stent prior to ureteroscopy Presence of any indwelling nephrostomy tube prior to ureteroscopy Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery Renal stone located in calyceal diverticulum No indication for stent placement (e.g. spontaneous passage) Bladder stone location. Pregnancy or lactation Known allergic reactions to polyurethane or silicone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyran Groce
Phone
734-998-0561
Email
kyrang@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bronson Conrado
Phone
734-763-0383
Email
bconrado@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD, MS, FRCS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD, MS, FRCS
Phone
734-763-2797
Email
kghani@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD, MS, FRCS
Facility Name
Michigan Medicine
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD, MS, FRCS
Phone
734-763-2797
Email
kghani@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD, MS, FRCS
Facility Name
Chelsea Hospital (Saint Joseph Mercy)
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Dauw, MD
Phone
630-842-9558
Email
caseydau@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Casey Dauw, MD
First Name & Middle Initial & Last Name & Degree
John DiBianco, MD
Facility Name
Henry Ford Macomb Hospital
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Haddad, MD
Phone
586-247-4247
Email
jhaddad1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Joseph Haddad, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Leavitt, MD
Phone
313-916-1941
Email
dleavit1@hfhs.org
First Name & Middle Initial & Last Name & Degree
David Leavitt, MD
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49456
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Pimentel, MD
Phone
616-258-4010
Email
hpimente100@gmail.com
First Name & Middle Initial & Last Name & Degree
Hector Pimentel, MD
Facility Name
Ascension Hospital (Comprehensive Urology)
City
Novi
State/Province
Michigan
ZIP/Postal Code
48374
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wenzler, MD
Phone
248-569-4897
Email
DWenzler@urologist.org
First Name & Middle Initial & Last Name & Degree
David Wenzler, MD
Facility Name
William Beaumont Hospital (Michigan Institute of Urology)
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank N Burks, MD
Email
fburks@urology.org
First Name & Middle Initial & Last Name & Degree
Frank N Burks, MD
Facility Name
William Beaumont Hospital (Michigan Institute of Urology)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank N Burks, MD
Email
fburks@urology.org
First Name & Middle Initial & Last Name & Degree
Frank N Burks, MD
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Leavitt, MD
Phone
313-916-1941
Email
dleavit1@hfhs.org
First Name & Middle Initial & Last Name & Degree
David Leavitt, MD
Facility Name
Henry Ford Wyandotte Hospital
City
Wyandotte
State/Province
Michigan
ZIP/Postal Code
48192
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveen Kachroo, MD
Phone
734-287-9399
Email
NKACHRO1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Naveen Kachroo, MD
Facility Name
Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Kleer, MD
Phone
734-649-1207
Email
Eduardo_Kleer@ihacares.com
First Name & Middle Initial & Last Name & Degree
Eduardo Kleer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

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