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. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Agrawal 2009.

Methods
  • Study design: RCT.

  • Study duration: September 2004 to August 2007.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: India.

  • Setting: single centre.

  • Patients with stone < 10 mm in size in the distal ureter; evaluated with KUB, US, intravenous urography, and NCCT in selected patients.

  • Number: treatment group 1: 34; treatment group 2: 34; control group: 34.

  • Median age (range, years): treatment group 1: 31.4 (15‐56); treatment group 2: 38.7 (19‐60); control group: 35.3 (22‐58).

  • Sex, M/F: treatment group 1: 26/8; treatment group 2: 28/6; control group: 24/10.

  • Exclusion criteria: UTI; severe hydroureteronephrosis; diabetes mellitus; multiple stones; hypotension; pregnancy; previous spontaneous stone expulsion; distal ureteral surgery; history of intake of warfarin/alpha‐blocker/calcium channel blocker/steroids and cimetidine.

Interventions Treatment group 1
  • Tamsulosin 0.4 mg once daily.


Treatment group 2
  • Alfuzosin 10 mg once daily.


Control group
  • Placebo.


All groups received 75 mg diclofenac intramuscularly and were advised to drink at least 3 L of fluids.
Outcomes
  • Stone passage.

  • Time for passage.

  • Total diclofenac dosage.

  • Number of pain episodes.

Funding sources None.
Declarations of interest None.
Notes Follow‐up weekly with KUB and US.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients were randomized to 3 groups."
Comment: Randomisation was stated, but no information on method used was available; therefore risk of selection bias was considered to be unclear.
Allocation concealment (selection bias) Unclear risk No quotes available. Insufficient information to permit judgement.
Comment: Owing to insufficient information, risk of allocation concealment was considered to be unclear.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No quotes available. No blinding described.
Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No quotes available. No blinding of outcome assessments described.
Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: “Spontaneous stone expulsion was observed in 28 of 34 patients (82.3%) in group 1, 24 of 34 (70.5%) in group 2, and 12 of 34 (35.2%) patients in group 3.”
Comment: Stone expulsion rate was reported for all participants; therefore, probably none were lost to follow‐up and accordingly risk of bias was considered low.
Selective reporting (reporting bias) Low risk No quotes available. Expected outcomes were reported according to objectives.
Comment: Risk of reporting bias was therefore considered to be low.
Other bias Low risk No quotes available. The study appears to be free of other sources of bias.
Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.