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

NCT07580963 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 25-09029359
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Stent-Related Symptom

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• Difference in the rate of adverse events between the two treatment arms.

  From enrollment until 30 days after end of treatment, an average of 5 weeks.

Study Arms (2)

Variable length ureteral stent

ACTIVE COMPARATOR

Device: Variable length ureteral stent

Image-informed length ureteral stent

EXPERIMENTAL

Device: Image-informed length ureteral stent

Interventions

Variable length ureteral stent DEVICE

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.

Variable length ureteral stent

Image-informed length ureteral stent DEVICE

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.

Image-informed length ureteral stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork-Presbyterian Hospital Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Study Officials

• Luay Alshara, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

212-746-4739; xij2004@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)