Ureteral Stent Study

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Device: Cook Sof-Flex® Double Pigtail Ureteral Stent; Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin

• Registration Number: NCT03043612
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-10
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Status Verified: 2017-06
• Primary Completion: 2017-06-16
• Study Completion: 2017-06-30
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ureteral Control Stent	Cook Sof-Flex® Double Pigtail Ureteral Stent	Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent
Ureteral Study Stent	Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin	Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication

Primary Outcome Measures

Name	Time	Method
Patient-reported body pain score	7-days post stent placement	Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms

Trial Locations

Locations (1)

Prince of Wales/Chinese University of Hong Kong; 🇭🇰 Sha Tin, Hong Kong