Study Evaluating the Helical Ureteral Stent

NCT01739725 | Completed DMC

• 1 other identifier: H11-03073
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi

Keywords

kidney stones, ureteral stent, pain,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent of patients requesting intervention during the stent indwell period

  1-2 weeks

Study Arms (1)

Helical stent insertion

EXPERIMENTAL

Study participants will receive the helical stent

Device: Stent insertion

Interventions

Stent insertion DEVICE

The patient will receive the helical stent

Helical stent insertion

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
• 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

You may not qualify if:

• 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
• \. 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Kidney Calculi; Pain

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ben Chew, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)