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

Trial Summary

What is the purpose of this trial?

This is a prospective randomized controlled trial designed to assess the differences in postoperative symptoms related to placement of a 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, 4.8Fr Percuflex ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 272 participants will be enrolled and will be on study for up to approximately 10 weeks.

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 data supports the effectiveness of the treatment 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 hydrogel-coated stents are easier to insert and more visible on X-rays without increasing symptoms. ^{1 2 3 4 5}

How does the ureteral stent treatment for kidney stones differ from other treatments?

Ureteral stents are unique because they are small tubes inserted into the ureter (the duct that carries urine from the kidney to the bladder) to help urine pass more easily, which is different from other treatments like medication or surgery that aim to break down or remove the stones directly. ^{6 7 8 9 10}

Research Team

Ali Antar, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An in vivo evaluation of a novel spiral cut flexible ureteral stent. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ureteral stents: impact of diameter and composition on patient symptoms. [2022]

3. United States 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. [2020]

4. Germany 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. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Impact of differential ureteral stent diameters on clinical outcomes after ureteroscopy intracorporeal lithotripsy: A systematic review and meta-analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Tracheal reaction to three different intraluminal stents in an animal model of tracheomalacia. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Dentinal Tubule Penetration of Tricalcium Silicate Sealers. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Fluoride release from orthodontic band cements-a comparison of two in vitro models. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Stenting of femoropopliteal lesions using interwoven nitinol stents. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Biocompatibility and pro-mineralization effect of tristrontium aluminate cement for endodontic use. [2022]