Renal StoneBLUESNCT05026710

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

A study testing Silicone (Coloplast Imajin Hydro) ureteral stent and Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer) in people with Renal Stone and Ureteral Stone, run by University of Michigan at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Stone, Ureteral Stone
What is being tested?: Silicone (Coloplast Imajin Hydro) ureteral stent and Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 10 sitesUnited States
Study dates: 2 Dec 2021to 21 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Michigan Medicine
Ann Arbor, Michigan, 48109
Michigan Medicine
Brighton, Michigan, 48116
Chelsea Hospital (Saint Joseph Mercy)
Chelsea, Michigan, 48118
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
Henry Ford Hospital
Detroit, Michigan, 48202
Ascension Hospital (Comprehensive Urology)
Novi, Michigan, 48374
William Beaumont Hospital (Michigan Institute of Urology)
Royal Oak, Michigan, 48073
William Beaumont Hospital (Michigan Institute of Urology)
Troy, Michigan, 48085
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study

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.

Conditions: Renal Stone, Ureteral Stone
Being tested: Silicone (Coloplast Imajin Hydro) ureteral stent, Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)
Keywords: Ureteral stent, Ureteroscopy, Lithotripsy
Medical subject headings: Nephrolithiasis, Ureterolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Silicone (Coloplast Imajin Hydro) ureteral stentDevice
During the end of the standard of care ureteroscopy the silicone stent will be placed.
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)Device
During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.

Study groups in NCT05026710
Study group	Role	What they receive
Silicone (Coloplast Imajin Hydro) ureteral stent	Experimental	Not described Receives: Device: Silicone (Coloplast Imajin Hydro) ureteral stent
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).	Experimental	Not described Receives: Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)

What is being measured

The primary outcome is the main question the study is designed to answer.

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 each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Measured: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Measured: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.

Secondary outcomes (7)

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 each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery.
Measured: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery.
Measured: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
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. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother). Change is defined as the difference in LURN SI-10 total score from baseline to 7-10 days after surgery.
Measured: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
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. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother). Change is defined as the difference in LURN SI-10 total score from baseline to 4-6 weeks after surgery.
Measured: : Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Composite Healthcare Utilization Metric Within 30 Days (WinRatio)
WinRatio composite healthcare utilization score ranges from 0 to 5 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 0=no HCU, 1=phone call or EMR message, 2=office visit, 3= Emergency Department visit, 4=Unplanned Hospitalization, 5=Hospitalization with ICU care
Measured: up to 30 days
Abnormal Imaging Findings Within 60 Days
Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit.
Measured: up to 60 days
Stone-free Rates Within 60 Days
Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging.
Measured: up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202121 Aug 2024

First posted30 Aug 2021
Study start2 Dec 2021
Primary completion1 Jul 2024
Study completion21 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal StoneStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05026710
Sponsor's protocol ID: HUM00199486
Acronym: BLUES
Status last verified: Oct 2025
First submitted: 23 Aug 2021
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Becker REN, DiBianco JM, Higgins AM, Konheim J, Kleer E, Leavitt D, King A, Kachroo N, Majdalany SE, Gandham D, Fernandez Moncaleano G, Conrado B, Shoemaker E, Daignault-Newton S, Dauw CA, Ghani KR. Daily Ecological Momentary Assessments of Pain and Ability to Work After Ureteroscopy and Stenting. J Endourol. 2024 Jun;38(6):545-551. doi: 10.1089/end.2023.0625.
PubMed 38545762

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study
ClinicalTrials.gov ID: NCT05026710
Acronym / sponsor ID: BLUES / HUM00199486
Conditions: Renal Stone, Ureteral Stone
Keywords: Ureteral stent, Ureteroscopy, Lithotripsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Coloplast A/S
Study start: 2 Dec 2021 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 21 Aug 2024 (actual)
First posted: 30 Aug 2021 (actual)
Results: Posted 28 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Silicone (Coloplast Imajin Hydro) ureteral stent	Experimental	Device: Silicone (Coloplast Imajin Hydro) ureteral stent
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).	Experimental	Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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
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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Silicone (Coloplast Imajin Hydro) ureteral stentDuring the end of the standard of care ureteroscopy the silicone stent will be placed.	Device	Silicone (Coloplast Imajin Hydro) ureteral stent
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.	Device	Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).

Primary outcome

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days
Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days
Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.

7 secondary outcomes

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks
Time frame: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks
Time frame: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days
Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Change in NIH LURN SI-10 Scores at 4 to 6 Weeks
Time frame: : Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Composite Healthcare Utilization Metric Within 30 Days (WinRatio)
Time frame: up to 30 days
Abnormal Imaging Findings Within 60 Days
Time frame: up to 60 days
Stone-free Rates Within 60 Days
Time frame: up to 60 days

Results and safety

Results posted to the registry on 28 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silicone (Coloplast Imajin Hydro) Ureteral Stent	110	107
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).	109	108

Primary outcome: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days

Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.. Mean (97.5% Confidence Interval). Unit: T-score

Measure	Silicone (Coloplast Imajin Hydro) Ureteral Stent n = 98	Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). n = 96
Value	4.28 (1.26 to 7.29)	2.92 (-0.07 to 5.91)

Silicone (Coloplast Imajin Hydro) Ureteral Stent vs Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).: p = 0.26, Regression, Linear

Population analysed: Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey

Primary outcome: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days

Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.. Mean (97.5% Confidence Interval). Unit: T-Score

Measure	Silicone (Coloplast Imajin Hydro) Ureteral Stent n = 98	Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). n = 96
Value	4.62 (1.76 to 7.47)	3.24 (0.23 to 6.24)

Silicone (Coloplast Imajin Hydro) Ureteral Stent vs Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).: p = 0.57, Regression, Linear

Population analysed: Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 60 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silicone (Coloplast Imajin Hydro) Ureteral Stent	3 of 107 (2.8%)	11 of 107 (10.3%)	0 of 107
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).	2 of 108 (1.9%)	10 of 108 (9.3%)	0 of 108

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38545762Becker REN, DiBianco JM, Higgins AM, Konheim J, Kleer E, Leavitt D, King A, Kachroo N, Majdalany SE, Gandham D, Fernandez Moncaleano G, Conrado B, Shoemaker E, Daignault-Newton S, Dauw CA, Ghani KR. Daily Ecological Momentary Assessments of Pain and Ability to Work After Ureteroscopy and Stenting. J Endourol. 2024 Jun;38(6):545-551. doi: 10.1089/end.2023.0625.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Khurshid Ghani, MD, MS, FRCS principal investigator

University of Michigan

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days (time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05026710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.