Differences in Postoperative Symptoms With Four Ureteral Stents

NCT ID: NCT06083051

Last Updated: 2025-06-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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6Fr Percuflex ureteral stents

Group Type ACTIVE_COMPARATOR

6Fr Percuflex ureteral stents

Intervention Type DEVICE

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

6Fr Tria ureteral stents

Group Type ACTIVE_COMPARATOR

6Fr Tria ureteral stents

Intervention Type 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

Group Type ACTIVE_COMPARATOR

4.8Fr Tria ureteral stents

Intervention Type 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

Group Type ACTIVE_COMPARATOR

4.8Fr Percuflex ureteral stents

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shuang Li

Role: CONTACT

608.263.8336

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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