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

Qadri 2014.

Study characteristics
Methods Study design: parallel RCT
Number of centers/setting: single center/not reported
Country: Pakistan
Dates of the study: July 2010 to December 2010
Participants Total number of participants randomized: 120
  • tamsulosin group: 60

  • control group: 60


Age (mean, years):
  • tamsulosin group: 39 (SD 14.7)

  • control group: 41 (SD 13.1)


Sex (M/F):
  • tamsulosin group: 41/19

  • control group: 48/12


Stone location:
  • tamsulosin group: 31 right renal/36 pelvis/17 lower renal/5 mid‐renal/2 upper renal

  • control group: 29 right renal/43 pelvis/13 lower renal/3 mid‐renal/1 upper renal


Stone size (mean, mm):
  • tamsulosin group: 1.12 (SD 0.31)

  • control group: 1.05 (SD 0.26)


Inclusion criteria: people with single radio‐opaque renal stone (0.5–2.0 cm)
Exclusion criteria: age extremes (18–60 years), recent open or endoscopic surgical intervention, presence of ureteral stent, radiolucent calculus, past unsuccessful ESWL, renal impairment (serum creatinine level above normal range), UTI, receiving calcium channel blocker or alpha‐blocker and corticosteroids, congenital urinary anomalies, severe vertebral malformation
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for max 8 weeks or until an alternative treatment was applied

  • standard care: oral diclofenac sodium 50 mg twice daily for 1 day


Control group: control
SWL:
  • Lithotriptor: electromagnetic shock wave generator, Storz Medical Modulith SLK

  • Power setting: max 70 kV, interval: 120/min

  • Number of shocks: max 4000, number of sessions: multiple; repeated every 2 weeks if significant fragments on x‐ray KUB

Outcomes Stone clearance rate, time to stone clearance (in weeks), mean intensity of pain, incidence of steinstrasse formation and incidence of auxiliary procedure required
  • How measured: VAS

  • Time point measured: every week, 8 weeks max


Subgroups: stone location, stone size, gender, age
Funding sources Not reported
Declarations of interest Not reported
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) Low risk Quote: "randomly assigned by envelope method to either standard therapy or alpha blocker."
Comment: appropriate method of sequence generation
Allocation concealment (selection bias) Unclear risk Comment: unclear whether allocation was concealed.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "randomized non‐placebo‐controlled study."
Comment: open label study; participants 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: investigators likely not blinded in this open label study.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (major adverse events) High risk Comment: investigators likely not blinded in this open label study.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "none of them 120 patients included in the study dropped out and all were followed till the end of the study."
Comment: no attrition.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) High risk Quote: "the subsequent sessions of SWL needed were given after every two weeks."
Comment: multiple SWL sessions; unclear how many per group.