Differences in Postoperative Symptoms With Four Ureteral Stents

University of Wisconsin (UW)

Status: Enrolling

Conditions: Urinary Stone

Treatments: Device: 6Fr Percuflex ureteral stents; Device: 4.8Fr Tria ureteral stents; Device: 6Fr Tria ureteral stents; Device: 4.8Fr Percuflex ureteral stents

Study type: Interventional

Funder types: Other

Identifiers

NCT06083051

Urology (Other Identifier)

Protocol Version 10/28/2024 (Other Identifier)

2023-0832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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272 participants in 4 patient groups

6Fr Percuflex ureteral stents

Active Comparator group

Treatment:

Device: 6Fr Percuflex ureteral stents

6Fr Tria ureteral stents

Active Comparator group

Treatment:

Device: 6Fr Tria ureteral stents

4.8Fr Tria ureteral stents

Active Comparator group

Treatment:

Device: 4.8Fr Tria ureteral stents

4.8Fr Percuflex ureteral stents

Active Comparator group

Treatment:

Device: 4.8Fr Percuflex ureteral stents