Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT06083051

Conditions

Urinary Stone

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

6Fr Percuflex ureteral stents

6Fr Tria ureteral stents

4.8Fr Tria ureteral stents

4.8Fr Percuflex ureteral stents

Study Details

Brief 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.

Conditions

Urinary Stone

Study ID

NCT06083051

Start date

Mar 21, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

272 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 6Fr Percuflex ureteral stents

active comparator: 6Fr Tria ureteral stents

active comparator: 4.8Fr Tria ureteral stents

active comparator: 4.8Fr Percuflex ureteral stents

Interventions

6Fr Percuflex ureteral stents

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

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.

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.

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.

Primary outcome measure

  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms [ Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index [ Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health [ Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance [ Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters [ Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms [ Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index [ Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health [ Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance [ Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) ]
  • Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters [ Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) ]

Central Contacts and Locations

Central contacts

Shuang Li

608.263.8336lis@urology.wisc.edu

Locations

University of Wisconsin School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-08.