Ureteral Stent Study

Cook Group

Status

Completed

Conditions

Urolithiasis

Treatments

Device: Cook Sof-Flex® Double Pigtail Ureteral Stent

Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03043612

13-15

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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