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

Micali 2007.

Study characteristics
Methods Study design: parallel RCT
Number of centers/setting: not reported
Country: Italy
Dates of the study: January 2003 to March 2005
Participants Total number of participants randomized: 113
  • tamsulosin group: 28

  • control group: 21

  • nifedipine group: 35

  • control 2 group: 29


Age (mean, years):
  • tamsulosin group: 45

  • control group: 46

  • nifedipine group 47

  • control 2 group: 48


Sex (M/F):
  • tamsulosin group: 16/12

  • control group: 11/10

  • nifedipine group: 23/12

  • control 2 group: 17/12


Stone location:
  • tamsulosin group: lower ureteral

  • control group: lower ureteral

  • nifedipine group: mid‐ureteral

  • control 2 group: mid‐ureteral


Stone size (mean, mm):
  • tamsulosin group: 10 (SD 2.59)

  • control group: 9.9 (SD 1.37)

  • nifedipine group: 10.4 (SD 2.27)

  • control 2 group: 10.25 (SD 1.35)


Inclusion criteria: people with radiopaque or radiolucent ureteral lithiasis selected for ESWL treatment
Exclusion criteria: signs and symptoms of UTI, pregnancy, multiple stones, severe hydronephrosis, hypotension, gastric ulcer disease, obesity, history of spontaneous stone expulsion, previous ureteral surgery
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for 14 days

  • standard care: diclofenac 75 mg intramuscular PRN and recommended oral 1.5–2 L water per day; ketoprofen 50 mg twice daily orally for 7 days as an antiedema agent in intervention groups only


Control group: standard care only (lower ureteral stones)
Comparator group: nifedipine 30 mg/day orally for 14 days
Control 2 group: standard care only (mid‐ureteral stones)
SWL:
  • Lithotriptor: Dornier Lithotripter S, an electromagnetic, third‐generation unit

  • Power setting: not reported, interval: not reported

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

Outcomes Stone free condition: complete absence of any stone or the presence of residual fragments < 3 mm in diameter
  • How measured: x‐ray KUB, ultrasound or excretory urography, or both

  • Time point measured: 30, 60 days


Subgroups: stone location (upper, middle, lower ureteral), follow‐up stage (1, 2 months)
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) Unclear risk Comment: randomization not specified but confirmed by authors; method of random sequence generation not specified.
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not addressed.
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: no mention of placebo; participants likely not blinded.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (stone clearance, time to stone clearance) High risk Comment: no mention of placebo; outcome assessors likely not blinded.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (major adverse events) High risk Comment: no mention of placebo; outcome assessors likely not blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "All the patients completed the study."
Comment: based on reported denominators, all randomized participants appear to have been included in analyses of all reported outcomes.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) Low risk Quote: "all patients underwent a single session of ESWL."
Comment: single SWL session; additional treatments accounted for as auxiliary treatments.