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

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: Not yet recruiting
• Conditions: Ureteral Stent-Related Symptom
• Intervention / Treatment: Device: Variable length ureteral stent; Device: Image-informed length ureteral stent

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: 212-746-4739; Email: xij2004@med.cornell.edu

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: Clinical Research Coordinator; Phone Number: 212-746-4739; Email: xij2004@med.cornell.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Differences in scores as measured by the USSQ between the two treatment arms.	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.	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.	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

Outcome Measure	Measure Description	Time Frame
Difference in the rate of adverse events between the two treatment arms.	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

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Luay Alshara, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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