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

Mohamed 2013.

Study characteristics
Methods Study design: prospective RCT
Number of centers/setting: single center/outpatient
Country: Egypt
Dates of the study: July 2010 to May 2012
Participants Total number of participants randomized: 130
  • tamsulosin group: 65

  • control group: 65


Age (mean, years):
  • tamsulosin group: 40.1 (SD 11.8)

  • control group: 43.8 (SD 10.4)


Sex (M/F):
  • tamsulosin group: 41/24

  • control group: 39/26


Stone location:
  • tamsulosin group: 25 upper ureteral/14 mid‐ureteral/26 lower ureteral

  • control group: 31 upper ureteral/13 mid‐ureteral/21 lower ureteral


Stone size (mean, mm): not reported
Inclusion criteria: solitary ureteric stone 5–15 mm diameter
Exclusion criteria: aged < 15 years, pregnancy, uncontrolled UTI, multiple ureteric stones, presence of ureteric stricture distal to stone, previous unsuccessful ESWL, concomitant use of calcium‐channel blockers or alpha‐blockers, uncorrected coagulation profile, severe vertebral malformation, morbid obesity, severe cardiopulmonary disorders, elevated serum creatinine (> 2 mg/dL), high grade hydronephrosis, diabetes mellitus, bladder outlet obstruction, neuropathic bladder, gastric ulcer disease (to avoid exacerbation of ulcer disease by analgesics)
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for 3 weeks

  • standard care: oral fluids, furosemide 20 mg every morning and diclofenac sodium tablets 50 mg 3 times/day or a 75 mg ampoule PRN


Control group: standard medical therapy alone
SWL:
  • Lithotriptor: electromagnetic lithotripter (Dornier SII, Germany) under fluoroscopic guidance for radio‐opaque stones and ultrasound guidance for 13 radiolucent stones

  • Power setting: mean 13.5 (range 12–15) kV, interval: 80–100/min

  • Number of shocks: max 3000–4000, number of sessions: max 3

Outcomes Primary: stone clearance, failure, clinically significant residual fragments, stone free, complications, auxiliary procedures
  • How measured: KUB

  • Time point measured: 30, 908 days


Secondary: expulsion time, median number of ESWL sessions, steinstrasse, cumulative diclofenac dose
Subgroups: stone location, stone size
Funding sources None
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) Low risk Quote: "the 130 and 30 patients were randomized into two equal groups using a computer program."
Comment: appropriate method of random sequence generation.
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not described.
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; 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 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 Comment: based on flow diagram, all randomized participants included in analyses of reported outcomes.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) Unclear risk Comment: several sessions; unclear how many participants received how many SWL sessions.