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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03043612
Other study ID # 13-15
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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