Clinical trial NCT05026710: Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
Official title: Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Ureteral Stone
Keywords: Ureteral stent
Ureteroscopy
Lithotripsy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2021-08-30
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 7 to 10 days
timeFrame: Baseline, 7 to 10 days
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 7 to 10 days
timeFrame: Baseline, 7 to 10 days
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 4 to 6 weeks
timeFrame: Baseline, 4 to 6 weeks
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 4 to 6 weeks
timeFrame: Baseline, 4 to 6 weeks
measure: Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 scores at 7 to 10 days
timeFrame: baseline, 7 to10 days
measure: Change in NIH LURN SI-10 scores at 4 to 6 weeks
timeFrame: Baseline, 4 to 6 weeks
measure: Composite healthcare utilization metric within 30 days
timeFrame: up to 30 days
measure: Abnormal imaging findings within 60 days
timeFrame: up to 60 days
measure: Stone-free rates within 60 days
timeFrame: up to 60 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Brighton
country: United States
facility: Michigan Medicine
state: Michigan
city: Chelsea
country: United States
facility: Chelsea Hospital (Saint Joseph Mercy)
state: Michigan
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Novi
country: United States
facility: Ascension Hospital (Comprehensive Urology)
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital (Michigan Institute of Urology)
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital (Michigan Institute of Urology)
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)
state: Michigan
Study officials:
affiliation: University of Michigan
name: Khurshid Ghani, MD, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: