NCT06083051

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will compare Ureteral Stent Symptom Questionnaire (USSQ) scores with each ureteral stent. Laser lithotripsy is a surgical procedure performed during stone surgeries. The Percuflex ureteral stent and Tria ureteral stent are FDA approved and clinically used in the United States. A total of 3 clinic visits (i.e., pre-operative visit, the stent removal 1-2 weeks after surgery, and one post-operative visit 3-6 weeks after surgery) in addition to the surgery will be needed for this study. The patient's demographic information and medical background data will be collected from the medical record. The USSQ will be administered twice: 1. At the time of stent removal (1-2 weeks after surgery ) (This is standard of care) 2. At the first postoperative follow-up after stent removal (3-6 weeks) (This is the standard of care). The following information will be collected as secondary outcomes: 1. WisQOL which will be administered three times. It is UW standard of care for stone patients to complete the WisQOL at every clinic visit. 2. ER visits documented in patients chart 3. Unscheduled clinic follow-up documented in patient chart 4. Additional prescriptions for stent related symptoms documented by patient chart 5. Stent complications by fluoroscopy or image 6. Physician evaluation of the stent. Physicians will complete a one page survey at the end of the case evaluating the stent.

Conditions

• Urinary Stone

Interventions

Type	Name	Description
DEVICE	6Fr Percuflex ureteral stents	The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
DEVICE	6Fr 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.
DEVICE	4.8Fr 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.
DEVICE	4.8Fr Percuflex ureteral stents	The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.

Timeline

• Start date: 2024-03-21
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-10-13
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study