Differences in Postoperative Symptoms With Four Ureteral Stents

Randomized Clinical Trial Evaluating Differences in Postoperative Symptoms With 6Fr Percuflex Ureteral Stents Versus 6Fr Tria Ureteral Stents Versus 4.8Fr Percuflex Ureteral Stents Versus 4.8Fr Tria Ureteral Stents After Laser Lithotripsy of Renal and Ureteral Stones

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Stone
• Intervention / Treatment: Device: 6Fr Percuflex ureteral stents; Device: 6Fr Tria ureteral stents; Device: 4.8Fr Tria ureteral stents; Device: 4.8Fr Percuflex ureteral stents

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuang Li; Phone Number: 608.263.8336; Email: lis@urology.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6Fr Percuflex ureteral stents	Device: 6Fr Percuflex ureteral stents; The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
Active Comparator: 6Fr Tria ureteral stents	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.
Active Comparator: 4.8Fr Tria ureteral stents	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.
Active Comparator: 4.8Fr Percuflex ureteral stents	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54.	at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37.	at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The General Health subscale score range from 6-28.	at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15.	at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.	at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54.	at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37.	at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-28.	at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15.	at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters	USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.	at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life measured by WISQOL Scores	WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 5-30. In the study, standardized total score is used. The range of the standardized total score is 0-100.	pre-operative visit (baseline), the stent removal 1-2 weeks after surgery (up to 4 weeks on study), and one post-operative visit 3-6 weeks after surgery (up to 10 weeks on study)
Number of Emergency Room Visits	Data collected from medical record.	up to 10 weeks
Number of Unscheduled Clinic Follow-Ups	Data collected from medical record.	up to 10 weeks
Summary of Additional Prescriptions for Stent-Related Symptoms	Data collected from medical record.	up to 10 weeks
Summary of Stent Complications		up to 10 weeks
Physician Evaluation of Stent: Survey Scores	Physicians will complete a one page survey at the end of the case evaluating the stent. Scores are from 0-5 where higher scores indicate a more positive evaluation.	up to 10 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Ali Antar, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Pathological Conditions, Signs and Symptoms; Urinary Calculi
• Other Study ID Numbers: 2023-0832; Urology (Other Identifier: UW Madison); Protocol Version 10/28/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No