Differences in Postoperative Symptoms With Four Ureteral Stents

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06083051
Status
Recruiting
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Conditions

  • Urinary Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 21, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
272 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin School of Medicine and Public HealthMadisonWisconsin53792-

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University of Wisconsin School of Medicine and Public Health· Madison, WI

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