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
University of Wisconsin, Madison
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.
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…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room. Exclusion Criteria: * 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.
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.
Location
- University of Wisconsin School of Medicine and Public HealthMadison, Wisconsin