Silodosin Versus Tamsulosin for Treatment of Ureteral Stones
Status:
Terminated
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency
Department (ED) visits. These stones can get caught in the ureter (the tube connecting the
kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as
the obstructing stone meets certain conditions and the patient isn't too sick, the patient is
usually sent home to try and pass the stone without surgery. This treatment is known as
medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin,
which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a
drug in the same class of tamsulosin, but which is thought to have a more selective action
and a quicker onset, which would theoretically make it better for aiding in kidney stone
passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs
to see how quickly they result in stone passage. Subjects are patients presenting to the ED
with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study
intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is
that silodosin will have decreased time to stone passage compared to tamsulosin.
Subjects who qualify and consent are randomized to a two-week course of either silodosin or
tamsulosin. They are also given prescriptions for standard of care medications for pain and
nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind
them of their follow-up appointment, ask about adverse events, and determine if their stone
has passed. They have a follow-up visit with study staff at the end of their two week
treatment to collect their pain diary, pill count, adverse events, and to determine if their
stone has passed. Study participation ends after this follow-up visit.