Study Evaluating the Helical Ureteral Stent

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01739725
First received: November 29, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Kidney Calculi
Device: Stent insertion
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Percent of patients who have pain during the stent indwell period [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

    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:

    1. Unscheduled Clinic visit, or
    2. Change in Pain Medication, or
    3. Early Stent Removal


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helical stent insertion
Study participants will receive the helical stent
Device: Stent insertion
The patient will receive the helical stent

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
  2. 19 years of age and older
  3. 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
  4. Willing to sign the Informed Consent Form
  5. Able to read, understand, and complete patient questionnaires

Exclusion Criteria:

  1. Active, symptomatic urinary tract infection
  2. Non-stone related distal ureteral obstruction or stricture
  3. Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
  4. Ureteral perforation or trauma
  5. History of bladder reconstruction or interstitial cystitis
  6. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739725

Contacts
Contact: Olga Arsovska 6048754111 ext 62421 olga.arsovska@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Olga Arsovska    6048754111 ext 62421    olga.arsovska@ubc.ca   
Principal Investigator: Ben Chew, MD         
Sub-Investigator: Ryan Paterson, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Ben Chew, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01739725     History of Changes
Other Study ID Numbers: H11-03073
Study First Received: November 29, 2012
Last Updated: June 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
kidney stones, ureteral stent, pain,

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on July 29, 2014