Study Evaluating the Helical Ureteral Stent

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Calculi

Intervention / Treatment
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* Device: Stent insertion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helical stent insertion<br>Study participants will receive the helical stent | Device: Stent insertion<br>* The patient will receive the helical stent<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney stones, ureteral stent, pain,