Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Silicone (Coloplast Imajin Hydro) ureteral stent
|
Device: Silicone (Coloplast Imajin Hydro) ureteral stent
During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
| Experimental: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
|
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 7 to 10 days [Baseline, 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.
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 7 to 10 days [Baseline, 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.
Secondary Outcome Measures
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 4 to 6 weeks [Baseline, 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.
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 4 to 6 weeks [Baseline, 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.
- 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 to10 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).
- Change in NIH LURN SI-10 scores at 4 to 6 weeks [Baseline, 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).
- Composite healthcare utilization metric within 30 days [up to 30 days]
Hospitalization and intensive care unit care Unplanned hospitalization Emergency department visit Ambulatory encounter: Clinic visit Ambulatory encounter: Phone call or message
- Abnormal imaging findings within 60 days [up to 60 days]
New or worsening hydronephrosis, hematoma, and/or urinoma of the operative renal unit.
- Stone-free rates within 60 days [up to 60 days]
No residual stone of the treated stone by postoperative imaging (CT, US, X-Ray, or any combination).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Stated willingness to comply with all study procedures and availability for the duration of the study
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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
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Renal stone defined as only renal location of stone(s).
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Ureteral stone defined as ureteral only or ureteral and renal stone(s).
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Planned unilateral ureteroscopy with stent placement without stent string.
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Ability to take oral medication.
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Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
Exclusion Criteria:
-
Known planned secondary or staged procedure
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Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney)
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Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder)
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Presence of any indwelling ureteral stent prior to ureteroscopy
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Presence of any indwelling nephrostomy tube prior to ureteroscopy
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Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery
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Renal stone located in calyceal diverticulum
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No indication for stent placement (e.g. spontaneous passage)
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Bladder stone location.
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Pregnancy or lactation
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Known allergic reactions to polyurethane or silicone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Michigan Medicine | Ann Arbor | Michigan | United States | 48109 |
| 2 | Michigan Medicine | Brighton | Michigan | United States | 48116 |
| 3 | Chelsea Hospital (Saint Joseph Mercy) | Chelsea | Michigan | United States | 48118 |
| 4 | Henry Ford Macomb Hospital | Clinton Township | Michigan | United States | 48038 |
| 5 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 6 | Spectrum Health | Grand Rapids | Michigan | United States | 49456 |
| 7 | Ascension Hospital (Comprehensive Urology) | Novi | Michigan | United States | 48374 |
| 8 | William Beaumont Hospital (Michigan Institute of Urology) | Royal Oak | Michigan | United States | 48073 |
| 9 | William Beaumont Hospital (Michigan Institute of Urology) | Troy | Michigan | United States | 48085 |
| 10 | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | United States | 48322 |
| 11 | Henry Ford Wyandotte Hospital | Wyandotte | Michigan | United States | 48192 |
| 12 | Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital) | Ypsilanti | Michigan | United States | 48197 |
Sponsors and Collaborators
- University of Michigan
- Coloplast A/S
Investigators
- Principal Investigator: Khurshid Ghani, MD, MS, FRCS, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00199486