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NCT Number: NCT07580963

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.

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Key information

Conditions

Ureteral Stent-Related Symptom

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Hospital Weill Cornell Medical Center

New York, 10065, United States

Location contact

Clinical Research Coordinator

CONTACT

[email protected]

212-746-4739

Luay Alshara, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  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.

Secondary outcomes

  1. 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.

Study contacts

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

Clinical Research Coordinator

CONTACT

[email protected]

212-746-4739

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
Jul 30, 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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