Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths

July 29, 2026 updated by: Weill Medical College of Cornell University
Placement of a ureteral stent at the end of ureteroscopy is commonly performed in endourology. The purpose of this study is to determine whether ureteral stents whose lengths are calibrated to a participant's specific ureteral length based on imaging are better tolerated than one-size-fits-all variable length ureteral stents. The investigators hypothesize that ureteral stent lengths calibrated to the ureteral length of each participant will be better tolerated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • NewYork-Presbyterian Hospital Weill Cornell Medical Center
        • Principal Investigator:
          • Luay Alshara, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female age 18-80 years
  2. Urolithiasis requiring ureteroscopic management with ureteral stent placement
  3. CT scan showing evidence of upper tract urolithiasis
  4. Negative pre-operative urine culture
  5. No symptoms of urinary tract infection

Exclusion Criteria:

  1. Known urinary tract anatomical abnormality, reconstructed urinary system, or congenital anomaly
  2. Ureteral stent inserted within the last 31 days
  3. History of peptic ulcer disease, symptomatic benign prostatic hyperplasia, interstitial cystitis, chronic pelvic pain syndrome, neurogenic lower urinary tract dysfunction, ureteral stricture disease
  4. Chronic narcotic use
  5. Allergy to non-steroidal anti-inflammatory medications
  6. Documentation of urinary tract infection within the last 31 days
  7. Pregnant
  8. Surgery being performed on transplanted kidney
  9. Unable to understand the questionnaire
  10. Requiring metallic stent placement
  11. Requiring bilateral or long-term stent insertion
  12. Requiring stent insertion after open or percutaneous renal procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Variable length ureteral stent
Device: Variable length ureteral stent
Placement of variable length ureteral stent at the end of ureteroscopy. The variable length stent is a one-size-fits-all stent that measures 22-30cm.
Experimental: Image-informed length ureteral stent
Device: Image-informed length ureteral stent
Placement of image-informed length ureteral stent at the end of ureteroscopy. The length will be 22cm, 24cm, or 26cm depending on the distance of the renal vein to ureterovesical junction on imaging.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in scores as measured by the USSQ between the two treatment arms.
Time Frame: 5 hours post-surgery
The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life.
5 hours post-surgery
Differences in scores as measured by the USSQ between the two treatment arms.
Time Frame: Post-intervention on Day 3
The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life.
Post-intervention on Day 3
Differences in scores as measured by the USSQ between the two treatment arms.
Time Frame: Post-intervention on Day 7
The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life.
Post-intervention on Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in the rate of adverse events between the two treatment arms.
Time Frame: From enrollment until 30 days after end of treatment, an average of 5 weeks.
Adverse events include but are not limited to early stent removal due to stent-related symptoms, stent migration, and failure of stent insertion.
From enrollment until 30 days after end of treatment, an average of 5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luay Alshara, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-09029359

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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