Evaluation of Ureteral Stents in the Management of Stone Disease
Primary Purpose
Urinary Stones, Urinary Tract Stones
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.
Sponsored by
About this trial
This is an interventional other trial for Urinary Stones
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age and willing and able to provide informed consent
Patients with current urinary stone disease, undergoing any of the following procedures:
- cystoscopy with stent placement
- ureteroscopy with intracorporeal lithotripsy
Exclusion Criteria:
- Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy)
- Patients requiring bilateral surgical stone management procedure
- Patients with any single stone exceeding 1.5 cm
- Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment
- Any patient who is on anticholinergic medication at baseline
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ureteral stent - soft, 6 French
Ureteral stent - hydrophobic, 6 French
Arm Description
Subjects randomized to soft stent, size 6 French
Subjects randomized to hydrophobic stent, size 6 French
Outcomes
Primary Outcome Measures
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT02211313
First Posted
August 4, 2014
Last Updated
May 22, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02211313
Brief Title
Evaluation of Ureteral Stents in the Management of Stone Disease
Official Title
Evaluation of Ureteral Stents in the Management of Stone Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of further funding.
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as treatment of urinary stone disease. Stents are designed to help provide drainage of the kidney in the setting of an obstructing stone, or postoperative swelling of the ureter. Though their presence is only temporary, stents are associated with a significant amount of patient discomfort and bother, which can negatively impact overall satisfaction. Over the past decades, there have been refinements in stent technology and usage philosophy. Smaller and softer stents are now available for use in patients, though studies evaluating the relative benefits have been conflicting. The investigators aim to evaluate the effect of stent size and composition upon outcomes after the treatment of stone disease, including patient comfort and satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stones, Urinary Tract Stones
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ureteral stent - soft, 6 French
Arm Type
Active Comparator
Arm Description
Subjects randomized to soft stent, size 6 French
Arm Title
Ureteral stent - hydrophobic, 6 French
Arm Type
Active Comparator
Arm Description
Subjects randomized to hydrophobic stent, size 6 French
Intervention Type
Device
Intervention Name(s)
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.
Intervention Description
Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
Primary Outcome Measure Information:
Title
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
Description
The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
Time Frame
Baseline, day 7 post stent removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years of age and willing and able to provide informed consent
Patients with current urinary stone disease, undergoing any of the following procedures:
cystoscopy with stent placement
ureteroscopy with intracorporeal lithotripsy
Exclusion Criteria:
Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy)
Patients requiring bilateral surgical stone management procedure
Patients with any single stone exceeding 1.5 cm
Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment
Any patient who is on anticholinergic medication at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana C Desai, M.D.
Organizational Affiliation
Washington UniversitySchool of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Ureteral Stents in the Management of Stone Disease
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