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

Janane 2014.

Study characteristics
Methods Study design: placebo controlled RCT
Number of centers/setting: presumed single center/not reported
Country: Morocco
Dates of the study: January 2008 to December 2012
Participants Total number of participants randomized: 356
  • tamsulosin group: 186

  • placebo group: 170


Age (mean, years):
  • tamsulosin group: 41.2 (SD 12.4)

  • placebo group: 43.4 (SD 12.2)


Sex (M/F):
  • tamsulosin group: 108/78

  • placebo group: 104/66


Stone location:
  • tamsulosin group: 30 upper calyces/23 mid‐calyces/79 renal pelvis/54 lumbar ureter

  • placebo group: 26 upper calyces/19 mid‐calyces/75 renal pelvis/50 lumbar ureter


Stone size (mean, mm):
  • tamsulosin group: 9.2 (SD 2.8)

  • placebo group: 9.2 (SD 3)


Inclusion criteria: people with lower ureteral stones undergoing ESWL
Exclusion criteria: UTI, multiple stones, severe hydronephrosis, solitary kidney, congenital urinary anomalies or previous ureteral surgery, severe obesity, pregnancy, lactation or previous treatment with alpha‐blockers
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for max 2 weeks or until an alternative treatment was applied

  • standard care: diclofenac 25 mg 3 times daily, recommended drink minimum 2 L water daily


Control group: placebo
SWL:
  • Lithotriptor: Storz medical lithotripter (MODULITH° SLX‐F2)

  • Power setting: not reported, interval: not reported

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

Outcomes Stone free rate, stone expulsion time, ureteral colic
  • How measured: abdominal ultrasound or IVP; CT

  • Time point measured: weekly, 3 months


Subgroups: stone size
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: none
Contact status: N/A
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "simple random allocation."
Comment: method of random sequence generation unclear.
Allocation concealment (selection bias) Unclear risk Quote: "simple random allocation."
Comment: allocation concealment not addressed.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "placebo‐controlled medical treatment."
Comment: no additional information provided to support that participants were adequately blinded.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (stone clearance, time to stone clearance) Unclear risk Comment: blinding of outcome assessors not addressed.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (major adverse events) Unclear risk Comment: blinding of outcome assessors not addressed.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: unable to assess what proportion of randomized participants were included in outcome analyses.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) Low risk Quote: "after single ESWL session…"
Comment: single SWL session.