Back to resultsStudy Evaluating the Helical Ureteral Stent
Primary Purpose
Kidney Calculi
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stent insertion
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Calculi focused on measuring kidney stones, ureteral stent, pain,
Eligibility Criteria
Inclusion Criteria:
- Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
- 19 years of age and older
- Having undergone Shockwave Lithotripsy-SWL, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires
Exclusion Criteria:
- Active, symptomatic urinary tract infection
- Non-stone related distal ureteral obstruction or stricture
- Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
- Ureteral perforation or trauma
- History of bladder reconstruction or interstitial cystitis
- Spinal cord injuries
6. Pregnant or lactating females 7. Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively 8. Patients with a solitary kidney 9. Chronic use of pain or anti-spasmodic medication for symptoms other than stone related pain 10. If in the opinion of the Investigator, the patient is not a suitable study candidate.
Sites / Locations
- University of British Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Helical stent insertion
Arm Description
Study participants will receive the helical stent
Outcomes
Primary Outcome Measures
Percent of patients who have pain during the stent indwell period
The primary objective is to decrease the percent of patients who have pain during the stent indwell period beyond protocol-defined postoperative pain therapy from 25% for standard stents (the Control Stent in previous studies) to 10% for the Helical Stent. The previous clinical trial found that patients with Percuflex Plus stents had pain 25.2% of the time following stent insertion (J Urol 183:1037, 2010).
Secondary Outcome Measures
Percent of patients requesting intervention during the stent indwell period
The secondary objective is to decrease the percent of patients requesting intervention during the stent indwell period.
Interventions are defined as the following actions taken due to pain:
Unscheduled Clinic visit, or
Change in Pain Medication, or
Early Stent Removal
Full Information
NCT ID
NCT01739725
First Posted
November 29, 2012
Last Updated
May 3, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01739725
Brief Title
Study Evaluating the Helical Ureteral Stent
Official Title
A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.
Detailed Description
Ureteral stents have been used for many years for a variety of clinical indications. Many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. There is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. This discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
kidney stones, ureteral stent, pain,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helical stent insertion
Arm Type
Experimental
Arm Description
Study participants will receive the helical stent
Intervention Type
Device
Intervention Name(s)
Stent insertion
Intervention Description
The patient will receive the helical stent
Primary Outcome Measure Information:
Title
Percent of patients who have pain during the stent indwell period
Description
The primary objective is to decrease the percent of patients who have pain during the stent indwell period beyond protocol-defined postoperative pain therapy from 25% for standard stents (the Control Stent in previous studies) to 10% for the Helical Stent. The previous clinical trial found that patients with Percuflex Plus stents had pain 25.2% of the time following stent insertion (J Urol 183:1037, 2010).
Time Frame
1-2 weeks
Secondary Outcome Measure Information:
Title
Percent of patients requesting intervention during the stent indwell period
Description
The secondary objective is to decrease the percent of patients requesting intervention during the stent indwell period.
Interventions are defined as the following actions taken due to pain:
Unscheduled Clinic visit, or
Change in Pain Medication, or
Early Stent Removal
Time Frame
1-2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
19 years of age and older
Having undergone Shockwave Lithotripsy-SWL, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days
Willing to sign the Informed Consent Form
Able to read, understand, and complete patient questionnaires
Exclusion Criteria:
Active, symptomatic urinary tract infection
Non-stone related distal ureteral obstruction or stricture
Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
Ureteral perforation or trauma
History of bladder reconstruction or interstitial cystitis
Spinal cord injuries
6. Pregnant or lactating females 7. Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively 8. Patients with a solitary kidney 9. Chronic use of pain or anti-spasmodic medication for symptoms other than stone related pain 10. If in the opinion of the Investigator, the patient is not a suitable study candidate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Evaluating the Helical Ureteral Stent
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