Ureteral Stent Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.

Official Title
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Cook Ureteral Stent Study

Conditions
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Urolithiasis

Intervention / Treatment
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* Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin
* Device: Cook Sof-Flex® Double Pigtail Ureteral Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral stenting is indicated Exclusion Criteria: Patient is unwilling or unable to sign and date the informed consent Patient is unwilling to comply with the follow-up study schedule Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study Patient is currently taking anti-cholinergic or other anti-spasm medications Patient is currently taking sildenafil, tadalafil, or vardenafil Patient has a known sensitivity to alpha-blocker medications Patient is currently undergoing chemotherapy or radiation therapy Patient has an active urinary tract infection Patient is in chronic renal failure, on hemodialysis, or on chronic peritoneal dialysis Patient requires bilateral shock wave lithotripsy, bilateral stents, or has bilateral symptomatic kidney stones Patient has had a ureteral stent within the past three months in either ureter Patient is unable to accurately detect or report bladder function or pain Patient has chronic pain

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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ureteral Study Stent<br>Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication | Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin<br>* Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis<br>|
| Active Comparator: Ureteral Control Stent<br>Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent | Device: Cook Sof-Flex® Double Pigtail Ureteral Stent<br>* Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported body pain score | Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms | 7-days post stent placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteroscopy for urolithiasis