Evaluation of Ureteral Stents in the Management of Stone Disease

Study Overview
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Brief Summary
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A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as treatment of urinary stone disease. Stents are designed to help provide drainage of the kidney in the setting of an obstructing stone, or postoperative swelling of the ureter. Though their presence is only temporary, stents are associated with a significant amount of patient discomfort and bother, which can negatively impact overall satisfaction. Over the past decades, there have been refinements in stent technology and usage philosophy. Smaller and softer stents are now available for use in patients, though studies evaluating the relative benefits have been conflicting. The investigators aim to evaluate the effect of stent size and composition upon outcomes after the treatment of stone disease, including patient comfort and satisfaction.

Official Title
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Evaluation of Ureteral Stents in the Management of Stone Disease

Conditions
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Urinary Stones, Urinary Tract Stones

Intervention / Treatment
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* Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age and willing and able to provide informed consent Patients with current urinary stone disease, undergoing any of the following procedures: cystoscopy with stent placement ureteroscopy with intracorporeal lithotripsy Exclusion Criteria: Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy) Patients requiring bilateral surgical stone management procedure Patients with any single stone exceeding 1.5 cm Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment Any patient who is on anticholinergic medication at baseline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ureteral stent - soft, 6 French<br>Subjects randomized to soft stent, size 6 French | Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.<br>* Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.<br>|
| Active Comparator: Ureteral stent - hydrophobic, 6 French<br>Subjects randomized to hydrophobic stent, size 6 French | Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.<br>* Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale. | Baseline, day 7 post stent removal |