RecruitingNot ApplicableNCT06083051

Differences in Postoperative Symptoms With Four Ureteral Stents

Randomized Clinical Trial Evaluating Differences in Postoperative Symptoms With 6Fr Percuflex Ureteral Stents Versus 6Fr Tria Ureteral Stents Versus 4.8Fr Percuflex Ureteral Stents Versus 4.8Fr Tria Ureteral Stents After Laser Lithotripsy of Renal and Ureteral Stones


Sponsor

University of Wisconsin, Madison

Enrollment

272 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria1

  • Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.

Exclusion Criteria7

  • Pregnant patients
  • Patients with transplant kidneys
  • Patients with irreversible coagulopathy
  • Patients with known ureteral stricture disease
  • Non-English speaking, vulnerable patients such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
  • Patients with planned staged procedures.
  • Patients who have stent placed before surgery.

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Interventions

DEVICE6Fr Percuflex ureteral stents

The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.

DEVICE6Fr Tria ureteral stents

The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 6 Fr is the diameter.

DEVICE4.8Fr Tria ureteral stents

The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 4.8 Fr is the diameter.

DEVICE4.8Fr Percuflex ureteral stents

The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.


Locations(1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

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NCT06083051


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