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

Yencilek 2010.

Methods
  • Study design: RCT.

  • Study duration: December 2004 and November 2008.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients with radio‐opaque proximal ureteral stones ≤ 10 mm; radiological evaluation with X‐ray, US, and in some cases NCCT.

  • Number: treatment group: 42; control group: 50.

  • Mean age ± SD, years: treatment group: 34.9 ± 11.8; control group: 33.5 ± 10.1.

  • Sex, M/F: treatment group: 24/18; control group: 30/20.

  • Exclusion criteria: severe hydronephrosis; solitary kidney; extra stone in the upper urinary system; previous surgical history; diabetes; hypertension; pregnancy; reduced kidney function.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.

  • Hyoscine‐N‐butylbromide 10 mg 3 times daily.


Control group/group 1
  • Hyoscine‐N‐butylbromide 10 mg 3 times daily.


All participants were instructed for adequate hydration.
Outcomes
  • Stone passage rate.

  • Mean stone expulsion time.

  • Mean VAS score.

  • Change in colic episodes.

  • Hospital re‐admission rates for colicky pain attacks.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up of 4 weeks.
Evaluation with X‐ray, US, or NCCT when stone passage occurred.
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, allocation concealment was considered to have 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: 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.