Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Variable length ureteral stent, Image-informed length ureteral stent.
- Who it may be relevant to
- Registry conditions: Ureteral Stent-Related Symptom. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Differences in scores as measured by the USSQ between the two treatment arms. [Time frame: 5 hours post-surgery]
- Differences in scores as measured by the USSQ between the two treatment arms. [Time frame: 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]
Secondary outcome measures (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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NewYork-Presbyterian Hospital Weill Cornell Medical Center — New York
Identifiers
NCT: NCT07580963 · 25-09029359