Tamsulosin for Ureteral Stones in the Emergency Department: A Randomized, Controlled Trial
Journal Club by
Dr.Suad Al-AbriR4
Sep 2009 Annals of Emergency Medicine
Introduction
• Renal colic , stones that are lodged in distal ureter• The main factors affecting the retention of ureteral
calculi are
* Ureteral muscle spasm,
* Submucosal edema,
* Pain, and infection • α-1 receptors are predominant in the ureteral
smooth muscle • Blockade of these α-adrenergic receptors would
decrease ureteral peristaltic amplitude and frequency
• Decreasing intraureteral pressure and allowing increased fluid transport to occur
Tamsulosin
• Selective α1A & α1D adrenoreceptor blocker
• Initial Rx of pts with lower urinary tract symptoms BPH
• The use of tamsulosin or other selective adrenoreceptor blockers +
• Standardized pain control regimen in pts with distal ureterolithiasis
• Medical expulsive therapy
Study objective
• To evaluate the efficacy of a 10-day • Course of tamsulosin in comparison to
standard therapy• For the treatment of adult ED patients with
distal ureterolithiasis
Study Design
• Randomized, controlled trial comparing • Rx standard analgesic therapies with a
combination of tamsulosin
&• Standard therapies• At ED Maine Medical Center• From August 2006 to November 2007
Inclusion Criteria
• 1- > or = 18 years of age• 2- Able to provide written informed consent• 3- Had CT confirmed diagnosis of a single
calculus in the distal third of the ureter (distal to the internal iliac vessels)
• Inconsistent with phleboliths• Determined by a board-certified radiologist
Exclusion Criteria
• 1- Allergy or sensitivity to tamsulosin or sulfa/sulfonamide allergy
• 2- Lithiasis of the ureteral intramural tract• 3-Acute or chronic renal failure• 4- Fever• 5-Presence of multiple ureteral stones• 6-Peptic ulcer disease; liver failure;
pregnancy; breastfeeding• 7- H/o urinary surgery, endoscopic
treatment,
Exclusion Criteria cont
• 8-Concomitant treatment with any of the following pharmaceuticals:
• α-lytic drugs, calcium channel antagonists, nitrates, and vardenafil hydrochloride.
• 9-Unable to use the study pain scale • 10-Unable to read, write, and speak
English
Interventions
• Randomly assigned to one of 2 study groups.
• Informed consent taken• Randomization was accomplished by
using a table of random numbers to assign sequentially numbered study packets to one of the study groups
• The information was contained in a sealed envelope within each study packet
Interventions
• On discharge from the ED, • Patients randomized to the standard
therapy group were provided with, • Instruction to use of, standardized doses
of ibuprofen (800 mg orally, 3 times a day) &
• Oxycodone (5 to 10 mg orally, every 4 to 6 hrs) prn
Interventions
• The Treatment group received tamsulosin hydrochloride 0.4 mg by mouth daily for 10 days +
• Standard analgesic therapy
• All subjects also received standard discharge instructions for renal colic and were given a urine strainer and instructions on straining their urine and collecting debris
• All patients were instructed to follow up with the hospital's on-call urologist in 10 to 14 days
The primary outcome
• Successful spontaneous ureteral stone expulsion at 14 days
Secondary outcomes
• 1-Time to stone passage• 2-Self-reported pain scores• 3-Number of colicky pain episodes• 4-Number of nscheduled return
ED/primary care visits• 5-Number of days of missed work/usual
function • 6-Amount of analgesic used• 7-Adverse events• All outcomes were evaluated at the 2, 5,
and 14-day telephone f/u sessions
Are the results of the study valid?
• 1- Was the assignment of pts to treatment randomized ?
• Yes,randomized, controlled trial
• 2- Were all patients who entered the trial properly accounted for and attributed at its conclusions?
• No
Are the results of the study valid?
• 3- Was follow-up complete?• No, complete follow-up data (for all 3
points of 2, 5, and 14 days) were not obtained for all subjects. 3 intervention group subjects and 2 standard therapy group subjects , lost f/u
• 4- Were pts analyzed in the groups to which they were randomized
• Yes
Are the results of the study valid?
• 5- Were patients, health workers and study personnel “blind” to treatment?
• No , No placebo , prescriptions for ibuprofen and oxycodone for all subjects , while providing prepackaged tamsulosin for those in the intervention group
• 6- Were study groups similar at the start of the trial?
• Yes
• 7- Aside from the experimental intervention , were the groups treated
equally ?
• Yes
What were the results?
• 1- How large was the treatment effect?
• No difference between treatment and control group
What were the results?
• 2-How precise was the estimate of the treatment effect ?
Will the results help me in caring for my
patients?
• 1- Can the results be applied to my patient care?
• Yes• 2- Were all clinically important outcome
considered ?• Yes• 3- Are the likely treatment benefits
worth the potential harms and costs?• None had reported adverse medication
effects in either group.
Sensitivity analysis
• An analytical procedure to determine how the results of a study would change if the facts were different or different studies included
• E.g for pt who lost to f/u , re-analysing the results with certain assumptions for those who lost to f/u
• R-analysis depend on new treatment , so if conclusion favours it , assume worse case scenario and
• If conclusion does not favour the new treatment assume best case scenario
Sensitivity Analyses
• 5 in stand & 3 tamsulosin unsure they had passed their stones or not 14d f/u
• Best-case sensitivity analysis, • Assumed that all 8 subjects 85.7% (n=30)
tamsulosin & 78.4% (n=29) standard had successful stone passage
• Difference between the groups=7.3%, P=.788
Sensitivity Analyses
• Assuming the worst case, that no subject with unknown stone passage had passed their stone,
• 69.2% (n=27) of tamsulosin and 64.9% (n=24) of standard would have experienced successful stone expulsion
• Difference of 4.3% between the groups, P=.821