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. 2020 Nov 12;2020(11):CD013393. doi: 10.1002/14651858.CD013393.pub2

Eryildirim 2016.

Study characteristics
Methods Study design: parallel RCT
Number of centers/setting: presumed single center/not reported
Country: Turkey
Dates of the study: January 2015 to December 2015
Participants Total number of participants randomized: 80
  • tamsulosin group: 40

  • control group: 40


Age (mean, years):
  • tamsulosin group: 39.04 (SD 12)

  • control group: 39.81 (SD 14.21)


Sex (M/F): not reported
Stone location: upper ureteral
Stone size: not reported
Inclusion criteria: > 18 years, treated with SWL for 5–10 mm single radio‐opaque upper ureteral stones (above iliac vessels)
Exclusion criteria: people with multiple stones, previous stone related procedures, obstruction, stent placement, auxiliary procedures, congenital anomalies, active UTI, pregnancy or renal insufficiency
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for up to 4 weeks

  • standard care: diclofenac sodium 75 mg enteric‐coated tablets for colic pain if needed


Control group: standard care only
SWL:
  • Lithotriptor: electromagnetic lithotriptor (Compact Sigma, Dornier MedTech, Wessling, Germany)

  • Power setting: not reported, interval: not reported

  • Number of shocks: not reported, number of sessions: 1

Outcomes Primary: HRQoL
  • How measured: HRQoL: EQ‐5D index scale and EQ‐5D VAS

  • Time point measured: up to 4 weeks


Secondary: stone free rate, analgesic requirement, number renal colic attacks and emergency room visits
Subgroups: not reported
Funding sources Not reported
Declarations of interest None
Notes Language of publication: English
Type of publication: full text
Date of contact attempt with study authors: 7 July 2019 – general inquiry to Dr Eryildirim
Contact status: no reply to‐date
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "a simple method by generating a random digit (0–60) was used."
Comment: appropriate method of random sequence generation was used.
Allocation concealment (selection bias) High risk Quote: "even numbers were used for cases undergoing SWL without MET and odd numbers were used for cases undergoing SWL procedure followed by MET initiation."
Comment: allocation not concealed.
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: no placebo use described; participants likely not blinded.
Blinding of outcome assessment (detection bias)
Investigator assessed; not susceptible (auxiliary treatments) Low risk Comment: outcome judged not susceptible to detection bias.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (stone clearance, time to stone clearance) High risk Comment: no blinding of outcome assessors described; likely not blinded.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (major adverse events) High risk Comment: no blinding of outcome assessors described; likely not blinded.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "following the exclusion of cases requiring DJ stent placement (a total of 12 cases; seven cases in group 1 and five cases in group 2)."
Comment: 10–19% of randomized participants not included in analyses of reported outcomes.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) Unclear risk Comment: unclear whether > 1 SWL session was administered.