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

Yuksel 2015.

Methods
  • Study design: RCT.

  • Study duration: March 2013 to May 2014.

  • Follow‐up/Treatment duration: 21 days.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients: detection of a distal ureteral stone 4‐10 mm in diameter.

  • Number: treatment group: 35; control group: 35.

  • Mean age ± SD, years: treatment group: 35.31 ± 11.55; control group: 35.23 ± 11.20.

  • Sex, M/F: treatment group: 20/15; control group: 19/35.

  • Exclusion criteria: younger than 18 or over 65 years of age; presence of multiple stones; grade 3 or 4 hydronephrosis; solitary or transplanted kidney; urinary tract infection; recurrent and persistent renal colic in reaction to analgesic administration; renal failure; allergic reaction to NSAID or alpha‐blocker treatment; hypotension; current intake of alpha‐blockers, CCBs, or steroids.

Interventions Treatment group
  • Silodosin 4 mg daily + diclofenac sodium on demand.


Control group
  • Diclofenac sodium on demand.


Both groups were also advised to remain active and to drink at least 2 L of water daily.
Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Number of renal colic episodes.

  • Need for analgesics.

  • Stone size.

Funding sources None stated.
Declarations of interest None.
Notes Follow‐up weekly visits with X‐ray or low‐dose CT.
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 selection bias was considered to have unclear risk of bias.
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) Unclear risk No quotes available.
Comment: Adverse effects were not described in the Results section, although they were stated as secondary outcomes in the Methods section; therefore risk of reporting bias was considered to be unclear.
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.