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Study Evaluating the Helical Ureteral Stent

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ClinicalTrials.gov Identifier: NCT01739725
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ben Chew, MD, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Kidney Calculi Device: Stent insertion Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Helical stent insertion
Study participants will receive the helical stent
Device: Stent insertion
The patient will receive the helical stent



Primary Outcome Measures :
  1. 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 :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739725


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

Responsible Party: Ben Chew, MD, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01739725     History of Changes
Other Study ID Numbers: H11-03073
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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