Ureteral Stents for Kidney Stones

Overseen By Shuang Li

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Transplant kidneys, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

272 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares different types of ureteral stents used after a procedure that breaks down kidney stones, focusing on whether certain stents cause fewer post-surgery symptoms. Participants will receive one of four stent types, including the 4.8Fr Tria ureteral stents, to determine which works best. Suitable candidates for this trial include individuals with kidney or ureteral stones who require endoscopic treatment with stent placement. As an unphased trial, this study provides an opportunity to contribute to research that may enhance post-surgery outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these ureteral stents are safe for treating kidney stones?

Research has shown that ureteral stents, like those tested in this trial, are generally safe and well-tolerated. A study on Percuflex stents indicated they are designed to stay in place, helping to prevent complications. Smaller stents, such as the 4.8Fr, have eased symptoms more effectively than larger ones, suggesting they might offer greater comfort for patients.

For Tria ureteral stents, studies suggest they may help reduce certain minerals in urine, potentially lowering the risk of crust formation on the stent. Both Percuflex and Tria stents have been used in medical settings, indicating they have undergone safety checks in people. However, like any medical device, some side effects may occur, but these are usually manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these ureteral stents for kidney stones because they explore different materials and sizes that could improve patient comfort and outcomes. The Tria and Percuflex stents come in both 4.8Fr and 6Fr sizes, which offer options for more personalized treatment. Tria stents, in particular, are known for their hydrogel coating, which might reduce irritation and encrustation, potentially leading to less discomfort and fewer complications than traditional stents. By comparing these new variations, the trial aims to identify stents that optimize performance and patient experience.

What evidence suggests that this trial's ureteral stents could be effective for kidney stones?

This trial will compare different ureteral stents for kidney stones. Research has shown that smaller ureteral stents, like the 4.8Fr Tria, which participants in this trial may receive, can improve urinary symptoms compared to larger ones. Studies indicate that patients with stents around 4.7 to 5-Fr often experience less pain and achieve better results. The 6Fr Percuflex stents, another option in this trial, are designed to remain in place and can be beneficial for large kidney stones. The 6Fr Tria stents, also being tested in this trial, appear promising, but more long-term research is needed to confirm their effectiveness in preventing build-up inside the stent. Overall, the size and material of the stent can influence comfort and recovery after kidney stone treatment. ^{3 4 5 6 7}

Who Is on the Research Team?

Ali Antar, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for patients with kidney or ureteral stones needing endoscopic treatment and stent placement. It's not for pregnant individuals, those with transplant kidneys, irreversible coagulopathy, known ureteral strictures, planned staged procedures, or pre-surgery stents.

Inclusion Criteria

I need a procedure for kidney or ureter stones that involves placing a stent.

Exclusion Criteria

I have a transplanted kidney.

I am scheduled for multiple surgery stages.

I have had a stent placed before undergoing surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Pre-operative visit to collect baseline data and administer WisQOL

1 week

1 visit (in-person)

Surgery and Initial Post-operative

Participants undergo laser lithotripsy and stent placement, followed by stent removal 1-2 weeks after surgery

1-2 weeks

1 surgery visit, 1 stent removal visit (in-person)

Post-operative Follow-up

Participants are monitored for symptoms and quality of life, including USSQ and WisQOL assessments

3-6 weeks

1 post-operative visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 4.8Fr Tria ureteral stents
• 6Fr Percuflex ureteral stents
• 6Fr Tria ureteral stents

Trial Overview The study compares postoperative symptoms from three types of ureteral stents after laser lithotripsy: a smaller 4.8Fr Tria stent and two larger ones - a 6Fr Percuflex and a 6Fr Tria. Participants are randomly assigned to one of these options.

How Is the Trial Designed?

Group I: 6Fr Percuflex ureteral stents Active Control 1 Intervention

Group II: 4.8Fr Percuflex ureteral stents Active Control 1 Intervention

Group III: 6Fr Tria ureteral stents Active Control 1 Intervention

Group IV: 4.8Fr Tria ureteral stents Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

In a study involving 141 patients, silicone-hydrocoated ureteral stents showed significantly less biofilm formation and mineral encrustation compared to Percuflex™ Plus stents after a 3-week indwelling period.

The results indicate that silicone stents are a safer option with a lower risk of complications related to encrustation, making them preferable for patients undergoing treatment for kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silicone-hydrocoated ureteral stents encrustation and biofilm formation after 3-week dwell time: results of a prospective randomized multicenter clinical study. Barghouthy, Y., Wiseman, O., Ventimiglia, E., et al.[2022]

In an animal model of tracheomalacia, the Nitinol stent showed superior biocompatibility and less reactivity with the tracheal mucosa compared to the Palmaz and NIR stents, resulting in significantly less granulation tissue formation.

The Nitinol stent also demonstrated better radial resistance and easier extraction, suggesting it may be the preferred option for treating tracheo- and bronchomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheal reaction to three different intraluminal stents in an animal model of tracheomalacia. Weinberg, M., Sandbank, J., Flumenblit, Y., et al.[2016]

In a study of 48 patients with femoropopliteal arterial disease, the Supera stent demonstrated high primary patency rates of 79.6% and secondary patency rates of 92.3% at midterm follow-up, indicating its effectiveness in maintaining blood flow.

The Supera stent showed no fractures during reinterventions, suggesting its durability and reliability, even in patients with long lesions greater than 30 cm, which had similar patency rates to shorter lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stenting of femoropopliteal lesions using interwoven nitinol stents. Brescia, AA., Wickers, BM., Correa, JC., et al.[2016]

Tristrontium aluminate (S3A) demonstrated biocompatibility and did not inhibit the proliferation of mouse dental papilla cells (MDPs), indicating its potential as a safe material for dental applications.

S3A showed superior pro-mineralization effects compared to mineral trioxide aggregate (MTA), with higher mineralized nodule formation and increased expression of key bone-related genes, suggesting it may enhance dental pulp repair effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biocompatibility and pro-mineralization effect of tristrontium aluminate cement for endodontic use. Adel, S., Hashimoto, K., Kawashima, N., et al.[2022]

The novel spiral cut flexible ureteral stent (Percuflex Helical) demonstrated equivalent flow characteristics to the standard control stent (Percuflex Plus) in both acute and chronic porcine models, indicating it effectively drains urine without obstruction.

Histopathologic evaluations showed no significant differences in tissue changes or encrustation between the novel and control stents, suggesting that the new stent is safe and does not cause additional harm to the ureter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vivo evaluation of a novel spiral cut flexible ureteral stent. Mucksavage, P., Pick, D., Haydel, D., et al.[2022]

In a study of 141 patients undergoing flexible ureteroscopy for kidney stones, the hydrocoated silicone stent (Coloplast Imajin® hydro) resulted in 25% lower body pain scores compared to the Percuflex™ Plus stent at day 20, indicating better patient comfort.

The silicone stent also showed significantly lower urinary symptom scores at multiple time points, suggesting it enhances quality of life without increasing adverse events or safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study. Wiseman, O., Ventimiglia, E., Doizi, S., et al.[2020]

In a study comparing fluoride release from different dental cements, the resin-modified glass ionomer cement (3M-Multicure) released the most fluoride, followed by conventional glass ionomer cement (Ketac-Cem), and then polyacid modified composite (Ultra Band-Lok), indicating that cement type significantly affects fluoride release.

The study found that the banded tooth model released 3-4 times more fluoride than the disc model for Ketac-Cem and 3M-Multicure, suggesting that the geometry and surface area of the cement application play a crucial role in fluoride release characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride release from orthodontic band cements-a comparison of two in vitro models. Caves, GR., Millett, DT., Creanor, SL., et al.[2019]

In a study involving 60 patients, three types of ureteral stents were analyzed, and it was found that the diameter and composition of the stents did not significantly affect symptoms like pain or urgency after placement.

The 6F hydrogel-coated stent was preferred for its ease of insertion and better visibility during imaging, although it did not lead to fewer irritative voiding symptoms compared to other stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureteral stents: impact of diameter and composition on patient symptoms. Candela, JV., Bellman, GC.[2022]

Tricalcium silicate sealers, including BC Sealer, QuickSet2, and NeoMTA Plus, demonstrated effective penetration into dental tubules, reaching depths of up to 2000 μm (2 mm) using both continuous wave (CW) and single-cone (SC) obturation techniques.

MTA Fillapex, a resin-based sealer, showed significantly better tubule penetration with a warm vertical technique compared to the SC technique at the 1-mm level, indicating that the choice of technique can influence the effectiveness of sealer penetration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dentinal Tubule Penetration of Tricalcium Silicate Sealers. McMichael, GE., Primus, CM., Opperman, LA.[2022]

Ureteral stents with smaller diameters (4.7-5-Fr) significantly improve urinary symptoms and body pain after placement compared to larger 6-Fr stents, based on a meta-analysis of 547 patients.

However, smaller stents have a higher risk of migration, indicating a trade-off between symptom relief and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of differential ureteral stent diameters on clinical outcomes after ureteroscopy intracorporeal lithotripsy: A systematic review and meta-analysis. Wu, G., Sun, F., Sun, K., et al.[2021]

Citations

1. auajournals.org auajournals.org/doi/10.1097/01.JU.0001110436.86964.27

Clinical Trials in Progress: Benign Disease Methods: This study will be a randomized trial comparing placement of a 6 Fr Percuflex ureteral stent, 4.8 Fr Percuflex stents with a 6 Fr Tria ...

2. withpower.com withpower.com/trial/phase-urinary-calculi-9-2023-e3b7e

Ureteral Stents for Kidney Stones The research suggests that smaller diameter ureteral stents (like the 4.8Fr Tria ureteral stents) may improve urinary symptoms compared to larger ones, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10172693/

A Systematic Review and Meta-analysis - PMC Magnetic ureteral stents have the advantages of a shorter removal time, less pain during removal, and low cost in comparison to conventional stents.

4. canjurol.com canjurol.com/html/subscriber/Spdf/V29I04/Cdn_JU29-I4_04_10_DrRamkumar.pdf

Considerations in ureteral stent selection in order to ... Results: Out of 2,970 identified studies, 26 met eligibility criteria. Most diameter studies found patients with. > 6Fr stents reported significantly increased ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4708572/

Advances in ureteral stents - PMC Results showed that the Uriprene stents began to degrade at 3 weeks and were completely degraded by 10 weeks. Uriprene stents provided similar drainage to ...

6. bostonscientific.com bostonscientific.com/en-US/products/stents--ureteral/percuflex.html

Percuflex™ Ureteral Stent A stent designed for migration resistance. With the firm Percuflex Ureteral Stent, you can be confident in your stent placement.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1607551X18300792

Comparison of 4.8 Fr and 6 Fr ureteral stents on ... Using 4.8 Fr JJ stents improves stent-related symptoms and decreases the USSQ score more than 6 Fr JJ stents.