Tamsulosin for Ureteral Stones in the Emergency Department: A Randomized, Controlled Trial

1. 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

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 • 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

3. 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

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

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

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

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,

8. 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

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

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

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

12. The primary outcome • Successful spontaneous ureteral stone expulsion at 14 days

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

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

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

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

19. What were the results? • 1- How large was the treatment effect? • No difference between treatment and control group

22. What were the results? • 2-How precise was the estimate of the treatment effect ?

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.

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

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

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