Ureteral Stent Study

Urolithiasis Clinical Trial

Official title:

Cook Ureteral Stent Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043612
• Other study ID #: 13-15
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: June 30, 2017
• Start date: June 10, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: June 2017
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 30, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Device:
• 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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales/Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported body pain score	Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms	7-days post stent placement