Ureteral Stent Study

Cook Ureteral Stent Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03043612

Enrollment

Registered

2017-02-06

Start date

2015-06-10

Completion date

2017-06-30

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Keywords

Ureteroscopy for urolithiasis

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.

Interventions

DEVICECook 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

DEVICECook Sof-Flex® Double Pigtail Ureteral Stent

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DEVICE_FEASIBILITY

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026