Ureteral Stent Study

NCT ID: NCT03043612

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ureteral Study Stent

Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Ureteral Control Stent

Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent

Group Type ACTIVE_COMPARATOR

Cook Sof-Flex® Double Pigtail Ureteral Stent

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Cook Sof-Flex® Double Pigtail Ureteral Stent

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chi-Fai Ng

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Locations

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Prince of Wales/Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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13-15

Identifier Type: -

Identifier Source: org_study_id

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