Differences in Postoperative Symptoms With Four Ureteral Stents
NCT ID: NCT06083051
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
272 participants
INTERVENTIONAL
2024-03-21
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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6Fr Percuflex ureteral stents
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
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
89 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Ali Antar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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Urology
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 10/28/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0832
Identifier Type: -
Identifier Source: org_study_id
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