Differences in Postoperative Symptoms With Four Ureteral Stents

NCT06083051 | Recruiting FDA Device

• 3 other identifiers: 2023-0832UrologyProtocol Version 10/28/2024
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Stone

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (6)

• Change in Quality of Life measured by WISQOL Scores

  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

  up to 10 weeks

• Number of Unscheduled Clinic Follow-Ups

  up to 10 weeks

• Summary of Additional Prescriptions for Stent-Related Symptoms

  up to 10 weeks

• Summary of Stent Complications

  up to 10 weeks

Study Arms (4)

6Fr Percuflex ureteral stents

ACTIVE COMPARATOR

Device: 6Fr Percuflex ureteral stents

6Fr Tria ureteral stents

ACTIVE COMPARATOR

Device: 6Fr Tria ureteral stents

4.8Fr Tria ureteral stents

ACTIVE COMPARATOR

Device: 4.8Fr Tria ureteral stents

4.8Fr Percuflex ureteral stents

ACTIVE COMPARATOR

Device: 4.8Fr Percuflex ureteral stents

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 Percuflex ureteral stents

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.

6Fr Tria ureteral stents

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 Tria ureteral stents

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.

4.8Fr Percuflex ureteral stents

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Antar, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Li

CONTACT

608.263.8336; lis@urology.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: March 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)