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Urinary StoneNCT06083051

Differences in Postoperative Symptoms With Four Ureteral Stents

A study testing 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents and 4.8Fr Tria ureteral stents in people with Urinary Stone, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Urinary Stone
What is being tested?
6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents and 4.8Fr Tria ureteral stents
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
1 siteUnited States
Study dates
21 Mar 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792

    Recruiting

Other trials in United States

About this study

Official 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

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.

Read the 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.
Conditions
Urinary Stone
Being tested
6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, 4.8Fr Tria ureteral stents, 4.8Fr Percuflex ureteral stents
Medical subject headings
Urinary Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6Fr Percuflex ureteral stentsDevice

    The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.

  • 6Fr Tria ureteral stentsDevice

    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 stentsDevice

    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 stentsDevice

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

Study groups in NCT06083051
Study groupRoleWhat they receive
6Fr Percuflex ureteral stentsActive comparatorNot described
Receives: Device: 6Fr Percuflex ureteral stents
6Fr Tria ureteral stentsActive comparatorNot described
Receives: Device: 6Fr Tria ureteral stents
4.8Fr Tria ureteral stentsActive comparatorNot described
Receives: Device: 4.8Fr Tria ureteral stents
4.8Fr Percuflex ureteral stentsActive comparatorNot described
Receives: Device: 4.8Fr Percuflex ureteral stents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Secondary outcomes (6)
  1. 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.

    Measured: 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)

  2. Number of Emergency Room Visits

    Data collected from medical record.

    Measured: up to 10 weeks

  3. Number of Unscheduled Clinic Follow-Ups

    Data collected from medical record.

    Measured: up to 10 weeks

  4. Summary of Additional Prescriptions for Stent-Related Symptoms

    Data collected from medical record.

    Measured: up to 10 weeks

  5. Summary of Stent Complications

    Measured: up to 10 weeks

  6. 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.

    Measured: up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start21 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06083051
Sponsor's protocol ID
2023-0832
Other IDs
Urology, Protocol Version 10/28/2024
Status last verified
Jun 2026
First submitted
9 Oct 2023
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents and 4.8Fr Tria ureteral stents in people with Urinary Stone, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuang Li (608.263.8336, lis@urology.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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