NCT05026710 - Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Renal Stone Ureteral Stone

Interventions

Silicone (Coloplast Imajin Hydro) ureteral stentDEVICE

During the end of the standard of care ureteroscopy the silicone stent will be placed.

Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)DEVICE

During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Michigan Medicine

Ann Arbor, Michigan, United States

Michigan Medicine

Brighton, Michigan, United States

Chelsea Hospital (Saint Joseph Mercy)

Chelsea, Michigan, United States

Outcomes

Primary Outcomes

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 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.

Time frame: 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-interference at 7 to 10 Days

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.

Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.

Secondary Outcomes

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 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 4-6 weeks after surgery.

Time frame: 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

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 4-6 weeks after surgery.