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

Singh 2011a.

Study characteristics
Methods Study design: prospective RCT
Number of centers/setting: single center/outpatient
Country: India
Dates of the study: January 2006 to June 2008
Participants Total number of participants randomized: 120
  • tamsulosin group: 60

  • control group: 60


Age (mean, years):
  • tamsulosin group: 34.2 (SD 13.9)

  • control group: 36 (SD 12.2)


Sex (M/F):
  • tamsulosin group: 42/18

  • control group: 42/17


Stone location: lower ureter
Stone size: not reported
Inclusion criteria: consecutive patients ages > 18 years with symptomatic, unilateral, solitary lower ureteric calculus confirmed by abdominal x‐ray and sonography KUB 4–12 mm in major axis
Exclusion criteria: active UTI, fever, acute renal failure, chronic renal failure, history of urinary tract surgery or endoscopic treatment, uncorrected distal obstruction, severe hydronephrosis, pregnancy, concomitant treatment with alpha‐blockers, calcium channel blockers, steroids, morbid obesity, history of previous failed ESWL
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for 1 month or complete clearance of stone, whichever was earlier

  • standard care: advised to take 2500 mL fluid daily, antibiotics and analgesic diclofenac PRN during the study period


Control group: control
SWL:
  • Lithotriptor: electromagnetic Lithotripter (HK–ESWL–VI Shenzhen, China)

  • Power setting: 12–15 kV, interval: not reported

  • Number of shocks: max 3000, number of sessions: 1

Outcomes Doses of analgesic required, stone free rate, clearance time, any complications
  • How measured: x‐ray, ultrasound KUB

  • Time point measured: weekly through 4 weeks


Subgroups: stone size (4–7 mm, 8–12 mm)
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 Comment: method of random sequence generation unclear.
Allocation concealment (selection bias) Unclear risk Comment: unclear whether allocation was concealed.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "open label study."
Comment: 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: 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: "one patient from control group was withdrawn from the study due to severe colic and underwent ureteroscopy."
Comment: low loss‐to‐follow‐up rate.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) Low risk Quote: "single session of ESWL."
Comment: 1 SWL session was administered.