What side effects are associated with this type of intervention?

Common treatments for kidney stones include ureteroscopy with stent placement and shock wave lithotripsy. The use of ureteral stents, such as the Imajin silicone stent, can lead to side effects including discomfort, urinary frequency, urgency, hematuria (blood in urine), and infection. Silicone stents are hypothesized to have superior outcomes due to their material properties, potentially reducing irritation and encrustation compared to non-silicone stents. However, all stents carry risks of migration, blockage, and the need for additional procedures to remove or replace them.

What prior FDA approvals exist?

The FDA has approved various stents for the treatment of kidney stones, including both silicone and non-silicone options. Silicone stents, like the Imajin silicone stent being studied, are hypothesized to offer superior patient outcomes due to their material properties, such as increased flexibility and biocompatibility, which may reduce discomfort and complications. Non-silicone stents, typically made from polyurethane, are also commonly used but may not provide the same level of comfort and reduced side effects as silicone stents. The ongoing research aims to validate these potential benefits of silicone stents in clinical settings.

What other types of research exist?

Promising alternatives to the Imajin Silicone Stent for kidney stone patients in 2024 include bioabsorbable stents and stents with advanced coatings. Bioabsorbable stents, such as those made from self-reinforced poly L-lactic acid, offer the advantage of gradually dissolving in the body, reducing the need for a second procedure to remove the stent. Additionally, stents with nanoporous coatings, like those using aluminum oxide layers, can be loaded with drugs such as tacrolimus to reduce inflammation and improve biocompatibility. These innovations aim to enhance patient comfort, reduce complications, and improve overall outcomes.

← Back to Search

Silicone vs Non-Silicone Stents for Kidney Stones (BLUES Trial)

N/A

Waitlist Available

Led By Khurshid Ghani, MD, MS, FRCS

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned unilateral ureteroscopy with stent placement without stent string.

Renal stone defined as only renal location of stone(s). Ureteral stone defined as ureteral only or ureteral and renal stone(s).

Must not have

Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder)

Presence of any indwelling nephrostomy tube prior to ureteroscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 to 6 weeks

Awards & highlights

Summary

This trial is testing if a silicone stent works better for patients who have had surgery on their ureter. The silicone stent helps keep the ureter open so urine can flow easily. Silicone stents are generally better tolerated compared to other materials.

Who is the study for?

The BLUES trial is for individuals with kidney or ureter stones who can take oral medication and are willing to follow the study's procedures. They must have stones no larger than 2cm, need a stent without a string after surgery, and be able to complete surveys. Pregnant women, those allergic to polyurethane or silicone, with certain anatomical anomalies or prior urinary diversions cannot participate.

What is being tested?

This study compares two types of ureteral stents: Imajin silicone stents versus non-silicone polyurethane stents in patients undergoing ureteroscopy for stone removal. Participants will be randomly assigned one type of stent and asked to fill out questionnaires about their experience.

What are the potential side effects?

Potential side effects from the use of either silicone or non-silicone ureteral stents may include discomfort during urination, blood in urine, lower back pain, possible infection risk, and rare allergic reactions specific to material sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a procedure to examine my ureter with stent placement without a stent string.

Select...

My kidney stones are located only in my kidneys or ureters.

Select...

I have kidney or ureter stones smaller than 2.0 cm.

Select...

I have a stone in my ureter, with or without kidney stones.

Select...

I can take pills by mouth.

Select...

I have kidney stones located only in my kidneys.

Select...

I can take pills by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery to redirect urine flow.

Select...

I have a tube inserted into my kidney.

Select...

I have a kidney stone in a specific part of my kidney.

Select...

I don't need a stent for my condition.

Select...

I have a scheduled follow-up surgery.

Select...

I have a unique kidney shape or position.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 7 to 10 days

Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 7 to 10 days

Secondary study objectives

Abnormal imaging findings within 60 days

Change in NIH LURN SI-10 scores at 4 to 6 weeks

Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 scores at 7 to 10 days

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Silicone (Coloplast Imajin Hydro) ureteral stentExperimental Treatment1 Intervention

Group II: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).Experimental Treatment1 Intervention

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney stones include shock wave lithotripsy and ureteroscopy with stenting. Shock wave lithotripsy uses high-energy sound waves to break kidney stones into smaller fragments that can be passed naturally. Ureteroscopy involves the insertion of a thin scope into the urinary tract to remove or break up stones, often followed by the placement of a stent to keep the ureter open and facilitate stone passage. The Imajin silicone stent, being studied for its material properties, may offer superior patient outcomes compared to non-silicone stents. Silicone's flexibility and biocompatibility can reduce discomfort, lower the risk of infection, and improve overall patient comfort and recovery, which is crucial for kidney stone patients who often experience significant pain and complications.

New concepts in shock wave lithotripsy.Renal calculi.