Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Stone, Ureteral Stone

Intervention / Treatment
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* Device: Silicone (Coloplast Imajin Hydro) ureteral stent
* Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silicone (Coloplast Imajin Hydro) ureteral stent<br> | Device: Silicone (Coloplast Imajin Hydro) ureteral stent<br>* During the end of the standard of care ureteroscopy the silicone stent will be placed.<br>|
| Experimental: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).<br> | Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)<br>* During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 7 to 10 days | 
| 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. | Baseline, 7 to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 4 to 6 weeks | 
| 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. | Baseline, 4 to 6 weeks | 
| 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). | baseline, 7 to10 days | 
| 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). | Baseline, 4 to 6 weeks | 
| 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 | up to 30 days | 
| Abnormal imaging findings within 60 days | New or worsening hydronephrosis, hematoma, and/or urinoma of the operative renal unit. | up to 60 days | 
| Stone-free rates within 60 days | No residual stone of the treated stone by postoperative imaging (CT, US, X-Ray, or any combination). | up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral stent, Ureteroscopy, Lithotripsy