Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Browse trials for

• Nephrolithiasis 324
• Ureterolithiasis 84

Keywords

• Ureteral stent
• Ureteroscopy
• Lithotripsy

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's enrollment of 224 is above the median of 92 across 257 interventional studies indexed under Nephrolithiasis.

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Study arms

• Experimental
  Silicone (Coloplast Imajin Hydro) ureteral stent

  Device: Silicone (Coloplast Imajin Hydro) ureteral stent

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

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

Interventions

• DeviceSilicone (Coloplast Imajin Hydro) ureteral stent

  During the end of the standard of care ureteroscopy the silicone stent will be placed.

• DeviceNon-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.

Primary outcomes

1. 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.

   Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.

2. 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.

   Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 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

   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.

   Time frame: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.

2. 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.

   Time frame: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 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

   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.

   Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.

4. 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.

   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.

5. 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

   Time frame: up to 30 days

6. Abnormal Imaging Findings Within 60 Days

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

   Time frame: up to 60 days

7. Stone-free Rates Within 60 Days

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

   Time frame: up to 60 days

Baseline characteristics

1 further baseline measures are reported on the registry.

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 ↗

Study documents

• Protocol and statistical analysis plan ↗ · Jun 12, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No