Ureteral Stent Study

June 30, 2017 updated by: Cook Group Incorporated

Cook Ureteral Stent Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Prince of Wales/Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ureteral Study Stent
Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication
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
Active Comparator: Ureteral Control Stent
Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported body pain score
Time Frame: 7-days post stent placement
Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms
7-days post stent placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Chi-Fai Ng, Prince of Wales Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2015

Primary Completion (Actual)

June 16, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe