Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2015-06-10
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
QUADRUPLE
Study Groups
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Ureteral Study Stent
Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication
Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin
Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Ureteral Control Stent
Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent
Cook Sof-Flex® Double Pigtail Ureteral Stent
Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Interventions
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Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin
Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Cook Sof-Flex® Double Pigtail Ureteral Stent
Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Chi-Fai Ng
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Locations
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Prince of Wales/Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Other Identifiers
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13-15
Identifier Type: -
Identifier Source: org_study_id
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