About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Variable length ureteral stent
DevicePlacement 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
DevicePlacement 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
Sponsors and contacts
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