Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Not Applicable

Completed

• Conditions: Renal Stone; Ureteral Stone
• Interventions: Device: Silicone (Coloplast Imajin Hydro) ureteral stent; Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)

• Registration Number: NCT05026710
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2021-12-02
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone (Coloplast Imajin Hydro) ureteral stent	Silicone (Coloplast Imajin Hydro) ureteral stent	-
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).	Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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).
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
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 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).
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.
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).

Trial Locations

Locations (8)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Ascension Hospital (Comprehensive Urology); 🇺🇸 Novi, Michigan, United States

Chelsea Hospital (Saint Joseph Mercy); 🇺🇸 Chelsea, Michigan, United States

Henry Ford Macomb Hospital; 🇺🇸 Clinton Township, Michigan, United States

Michigan Medicine; 🇺🇸 Brighton, Michigan, United States

Henry Ford West Bloomfield Hospital; 🇺🇸 West Bloomfield, Michigan, United States

William Beaumont Hospital (Michigan Institute of Urology); 🇺🇸 Troy, Michigan, United States

Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital); 🇺🇸 Ypsilanti, Michigan, United States