Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 224
- Locations
- 10
- Primary Endpoint
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
Intervention: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer) (Device)
Silicone (Coloplast Imajin Hydro) ureteral stent
Intervention: Silicone (Coloplast Imajin Hydro) ureteral stent (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days(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-intensity at 4 to 6 Weeks(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(Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.)
- Change in NIH LURN SI-10 Scores at 4 to 6 Weeks(: 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)(up to 30 days)
- Abnormal Imaging Findings Within 60 Days(up to 60 days)
- Stone-free Rates Within 60 Days(up to 60 days)
Investigators
Khurshid Ghani
Associate Professor of Urology
University of Michigan