Ureteral Stent Study

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.

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales/Chinese University of Hong Kong

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis

Cook Sof-Flex® Double Pigtail Ureteral Stent

Device

Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis

Primary outcomes

Patient-reported body pain score

Time frame: 7-days post stent placement

Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Cook Ureteral Stent Study

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Feb 6, 2017
Registry last updated: Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed