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

Sayed 2008.

Methods
  • Study design: RCT.

  • Study duration: October 2005 and July 2006.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Egypt.

  • Setting: single centre.

  • Patients aged 18‐62 years who had a unilateral distal ureteral stone (5‐10 mm); evaluated by KUB, US, and IV urography.

  • Number: treatment group: 45; control group: 45.

  • Mean age ± SD, years: treatment group: 39.39 ± 10.6; control group: 37.19 ± 9.8.

  • Sex, M/F: treatment group: 34/11; control group: 35/10.

  • Exclusion criteria: UTI; severe hydronephrosis; multiple stones; pregnancy; lactation; hypotension; ureteral stricture or a history of spontaneous stone passage; concomitant treatment with alphalytic drugs; beta‐blockers or calcium antagonists; desire of patient for immediate stone removal.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.

  • Standard therapy.


Control group
  • Standard therapy: hydration (at least 2 L water/d) and injection of 100 mg of diclofenac on demand.

Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Pain episodes.

  • Total analgesic dosage.

Funding sources None stated.
Declarations of interest None stated.
Notes Every week, a clinical examination was performed and KUB X‐rays and abdominal US were obtained.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No quotes available.
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, 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 No quotes available.
Comment: No participants lost to follow‐up; therefore risk of attrition bias was considered to be 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. 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.