Clinical trial NCT00199524: Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Official title: A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Calculi
Keywords: ureteroscopy
stone free
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2005-09-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary end point is the stone free rate at 3 months post ureteroscopy.
timeFrame: 3 months post ureteroscopy
Secondary outcomes:
measure: 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.
timeFrame: at time of intervention
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton Prostate and Urological Research Centre
state: Alberta
city: Vancouver
country: Canada
facility: The Prostate Centre at Vancouver General Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Centre for Advanced Urological Research at Queen's University
state: Ontario
city: London
country: Canada
facility: Urology at St. Joseph's Hospital, The University of Western Ontario
state: Ontario
city: Toronto
country: Canada
facility: Kidney Stone Program at St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Urology, St. Joseph's Hospital, The University of Western Ontario
name: Hassan Razvi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: