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Tamsulosin for Ureteral Stones in the Emergency Department: A Randomized, Controlled Trial Journal Club by Dr.Suad Al-Abri R4 Sep 2009 Annals of Emergency Medicine Slide 2 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 -1 receptors are predominant in the ureteral smooth muscle Blockade of these -adrenergic receptors would decrease ureteral peristaltic amplitude and frequency Decreasing intraureteral pressure and allowing increased fluid transport to occur Slide 3 Tamsulosin Selective 1A & 1D 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 Slide 4 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 Slide 5 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 Slide 6 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 Slide 7 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, Slide 8 Exclusion Criteria cont 8-Concomitant treatment with any of the following pharmaceuticals: -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 Slide 9 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 Slide 10 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 Slide 11 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 Slide 12 The primary outcome Successful spontaneous ureteral stone expulsion at 14 days Slide 13 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 Slide 14 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 Slide 15 Slide 16 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 Slide 17 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 Slide 18 Slide 19 What were the results? 1- How large was the treatment effect? No difference between treatment and control group Slide 20 Slide 21 Slide 22 What were the results? 2-How precise was the estimate of the treatment effect ? Slide 23 Slide 24 Slide 25 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. Slide 26 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 Slide 27 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 Slide 28 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 Slide 29