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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWeill Medical College of Cornell University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Variable length ureteral stentActive comparator 1 intervention
Group B: Image-informed length ureteral stentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 hours post-surgery
2

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.

Time frame
Post-intervention on Day 3
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.

Time frame
Post-intervention on Day 7

Secondary outcomes

1

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.

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

Other outcomes

Sponsors and contacts

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