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

Griwan 2010.

Methods
  • Study design: randomised prospective trial.

  • Study duration: unknown.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: India.

  • Setting: single centre.

  • Patients 18 years or older with unilateral distal ureteral stones measuring 4‐10 mm.

  • Number: treatment group: 30; control group: 30.

  • Mean age ± SD, years: treatment group: 34.20 ± 13.96; control group: 36.00 ± 12.22.

  • Sex, M/F: treatment group 2: 19/11; control group: 18/12.

  • Exclusion criteria: all cases having active urinary tract infection; fever; acute renal failure; chronic renal failure; history of urinary surgery or endoscopic treatment; uncorrected distal obstruction; marked hydronephrosis.

Interventions Treatment group
  • Tamsulosin 0.4 mg daily


Control group
  • Both groups received diclofenac 50 mg and Buscopan 10 mg orally on demand.

Outcomes Successful results were defined as complete stone passage; failure was considered if:
  • the participant failed to pass the stone at the end of 28 days; or

  • uncontrolled pain and/or uroseptic fever led to hospitalisation during the study period.

Funding sources None.
Declarations of interest None.
Notes Follow‐up weekly with KUB.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... were divided randomly."
Comment: Randomisation 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, allocation concealment was considered to be at unclear risk of bias.
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 No quotes available.
Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.
Selective reporting (reporting bias) High risk No quotes available.
Comment: Outcomes were not prespecified; therefore risk of reporting bias was considered to be high.
Other bias Low risk No quotes available. 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.