Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

Phase 4TerminatedNCT00199524

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's44 enrolled

Overview

Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3 months will be determined between the two groups. The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy will result in improved stone free rates at 3 months compared to ureteroscopy without use of a sheath.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Calculi

Interventions

Navigator Ureteral Access Sheath

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Upper ureteral (proximal to iliac vessels/iliac crest) calculi; * Renal calculi; * Normal renal function; * Any stone composition; * Single or multiple stones(planned treatment of all stones at this surgery); * Age \> 18 years; * Able and willing to return treatment centre for follow-up visits; AND * Signed study consent Exclusion Criteria: * Ureteric calculi distal to the level of the iliac vessels/iliac crest; * Failed ureteroscopy for same stone (i.e. has to be the first ureteroscopic procedure for this stone, however a prior failed extracorporeal shockwave lithotripsy (SWL) is acceptable); * Bilateral ureteroscopy; * If an adjunctive procedure is planned post ureteroscopy (e.g. percutaneous nephrolithotomy, SWL) (i.e. it is known preoperatively that a ureteroscopic procedure will not render the patient stone free and that ancillary procedures will be necessary); * If in the investigators opinion, enrollment would be not be appropriate; OR * Pregnancy

Locations (5)

Edmonton Prostate and Urological Research Centre

Edmonton, Alberta, Canada

The Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, Canada

Centre for Advanced Urological Research at Queen's University

Kingston, Ontario, Canada

Urology at St. Joseph's Hospital, The University of Western Ontario

London, Ontario, Canada

Kidney Stone Program at St. Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

The primary end point is the stone free rate at 3 months post ureteroscopy.

Time frame: 3 months post ureteroscopy

Secondary Outcomes

Secondary end points include operative and surgical factors such as operative time, stone size, stone location, stone composition, patient sex and the presence of a ureteric stent post-op.

Time frame: at time of intervention