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