Differences in Postoperative Symptoms With Four Ureteral Stents

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06083051
Study type	Interventional
Source	University of Wisconsin, Madison
Contact	Shuang Li
Phone	608.263.8336
Email	lis@urology.wisc.edu
Status	Recruiting
Phase	N/A
Start date	March 21, 2024
Completion date	July 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.