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Study Evaluating the Helical Ureteral Stent

This study has been completed.
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: November 29, 2012
Last updated: March 1, 2017
Last verified: March 2017
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
Kidney Calculi Device: Stent insertion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent

Resource links provided by NLM:

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 ]
    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 ]

    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

Enrollment: 17
Study Start Date: December 2012
Study Completion Date: December 2014
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.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01739725

Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z1M9
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Ben Chew, MD University of British Columbia
  More Information

Responsible Party: University of British Columbia Identifier: NCT01739725     History of Changes
Other Study ID Numbers: H11-03073
Study First Received: November 29, 2012
Last Updated: March 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi processed this record on September 21, 2017