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Ureteral Stent Study

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin
Cook Sof-Flex® Double Pigtail Ureteral Stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Urolithiasis focused on measuring Ureteroscopy for urolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales/Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ureteral Study Stent

Ureteral Control Stent

Arm Description

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

Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent

Outcomes

Primary Outcome Measures

Patient-reported body pain score
Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms

Secondary Outcome Measures

Full Information

First Posted
January 31, 2017
Last Updated
June 30, 2017
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03043612
Brief Title
Ureteral Stent Study
Official Title
Cook Ureteral Stent Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Ureteroscopy for urolithiasis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ureteral Study Stent
Arm Type
Experimental
Arm Description
Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication
Arm Title
Ureteral Control Stent
Arm Type
Active Comparator
Arm Description
Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent
Intervention Type
Device
Intervention Name(s)
Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin
Intervention Description
Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Intervention Type
Device
Intervention Name(s)
Cook Sof-Flex® Double Pigtail Ureteral Stent
Intervention Description
Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Primary Outcome Measure Information:
Title
Patient-reported body pain score
Description
Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms
Time Frame
7-days post stent placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Fai Ng
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales/Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Ureteral Stent Study

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