An interventional study of 6Fr Percuflex ureteral stents and 6Fr Tria ureteral stents in Urinary Stone, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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:
The following information will be collected as secondary outcomes:
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 272 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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Exclusion Criteria:
Device: 6Fr Percuflex ureteral stents
Device: 6Fr Tria ureteral stents
Device: 4.8Fr Tria ureteral stents
Device: 4.8Fr Percuflex ureteral stents
The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
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.
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.
The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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.
Time frame: 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.
Time frame: up to 10 weeks
Number of Unscheduled Clinic Follow-Ups
Data collected from medical record.
Time frame: up to 10 weeks
Summary of Additional Prescriptions for Stent-Related Symptoms
Data collected from medical record.
Time frame: up to 10 weeks
Summary of Stent Complications
Time frame: 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.
Time frame: up to 10 weeks
Plan to share: No
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