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NCT Number: NCT06083051

Differences in Postoperative Symptoms With Four Ureteral Stents

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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:

  • At the time of stent removal (1-2 weeks after surgery ) (This is standard of care)
  • 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:

  • WisQOL which will be administered three times. It is UW standard of care for stone patients to complete the WisQOL at every clinic visit.
  • ER visits documented in patients chart
  • Unscheduled clinic follow-up documented in patient chart
  • Additional prescriptions for stent related symptoms documented by patient chart
  • Stent complications by fluoroscopy or image
  • Physician evaluation of the stent. Physicians will complete a one page survey at the end of the case evaluating the stent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

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 Percuflex ureteral stents

Device

The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.

Primary outcomes

  1. Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms

    Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)

    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.

  2. Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index

    Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)

    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.

  3. Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health

    Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)

    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.

  4. Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance

    Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)

    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.

  5. Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters

    Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)

    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.

  6. Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms

    Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)

    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.

  7. Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index

    Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)

    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.

  8. Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health

    Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)

    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.

  9. Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance

    Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)

    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.

  10. Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters

    Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)

    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.

Secondary outcomes

  1. Change in Quality of Life measured by WISQOL Scores

    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)

    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.

  2. Number of Emergency Room Visits

    Time frame: up to 10 weeks

    Data collected from medical record.

  3. Number of Unscheduled Clinic Follow-Ups

    Time frame: up to 10 weeks

    Data collected from medical record.

  4. Summary of Additional Prescriptions for Stent-Related Symptoms

    Time frame: up to 10 weeks

    Data collected from medical record.

  5. Summary of Stent Complications

    Time frame: up to 10 weeks

  6. Physician Evaluation of Stent: Survey Scores

    Time frame: up to 10 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuang Li

CONTACT

[email protected]

608.263.8336

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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