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

Lawson Health Research Institute

Status and phase

Terminated

Phase 4

Conditions

Urinary Calculi

Treatments

Device: Navigator Ureteral Access Sheath

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00199524

R-05-002

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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