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Completed

NCT Number: NCT05026710

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

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.

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Key information

Conditions

Renal Stone Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Ureteral Diseases Ureteral Stone Ureterolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicone (Coloplast Imajin Hydro) ureteral stent

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. Composite Healthcare Utilization Metric Within 30 Days (WinRatio)

    Time frame: up to 30 days

    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

  6. Abnormal Imaging Findings Within 60 Days

    Time frame: up to 60 days

    Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit.

  7. Stone-free Rates Within 60 Days

    Time frame: up to 60 days

    Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Coloplast A/S

Registry information

Official study title

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

Acronym: BLUES

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2021
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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