Study Evaluating the Helical Ureteral Stent

A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent

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.

Study Overview

• Status: Completed
• Conditions: Kidney Calculi
• Intervention / Treatment: Device: Stent insertion

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
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Helical stent insertion; Study participants will receive the helical stent	Device: Stent insertion; The patient will receive the helical stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-2 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (ESTIMATE): December 3, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: kidney stones, ureteral stent, pain,
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: H11-03073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO