Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Renal Stone Clinical Trial

— BLUES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026710
• Other study ID #: HUM00199486
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: Elaina Shoemaker
• Phone: 734-764-3916
• Email: esekulos[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone
• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis

Intervention

Device:
• Silicone (Coloplast Imajin Hydro) ureteral stent
During the end of the standard of care ureteroscopy the silicone stent will be placed.
• 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.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan
United States	Michigan Medicine	Brighton	Michigan
United States	Chelsea Hospital (Saint Joseph Mercy)	Chelsea	Michigan
United States	Henry Ford Macomb Hospital	Clinton Township	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Ascension Hospital (Comprehensive Urology)	Novi	Michigan
United States	William Beaumont Hospital (Michigan Institute of Urology)	Royal Oak	Michigan
United States	William Beaumont Hospital (Michigan Institute of Urology)	Troy	Michigan
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	Henry Ford Wyandotte Hospital	Wyandotte	Michigan
United States	Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Abnormal imaging findings within 60 days	New or worsening hydronephrosis, hematoma, and/or urinoma of the operative renal unit.	up to 60 days
Secondary	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