Cook Ureteral Stent Study

Cook Group Incorporated1 site in 1 country56 target enrollmentJune 10, 2015

ConditionsUrolithiasis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Urolithiasis
Sponsor: Cook Group Incorporated
Enrollment: 56
Locations: 1
Primary Endpoint: Patient-reported body pain score
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 10, 2015

End Date

June 30, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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