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

Ateş 2012.

Study characteristics
Methods Study design: multicenter, prospective RCT
Number of centers/setting: multicenter/hospital
Country: Turkey
Dates of the study: April 2009 to October 2010
Participants Total number of participants randomized: 90
  • doxazosin controlled release group: not reported

  • control group: not reported


Age (mean, years):
  • doxazosin controlled release group: 38.35 (SD 11.41)

  • control group: 30.95 (SD 9.68)


Sex (M/F):
  • doxazosin controlled release group: 25/10

  • control group: 33/11


Stone location: upper ureteral
Stone size (mean, mm):
  • doxazosin controlled release group: 9.06 (SD 1.45)

  • control group: 8.30 (SD 2.51)


Inclusion criteria: people with renal colic, who were admitted to the emergency rooms or urology clinics and whose KUB graphs revealed radio‐opaque upper ureteral stones
Exclusion criteria: abnormal renal anatomy and function, use of medications that may have led to stone formation, pregnancy or suspicion of pregnancy, distal obstruction, history of previous urinary stone surgery, hydronephrosis grade > 1, presence of coagulopathy, active UTI, history of hypersensitivity for doxazosin, serum creatinine level > 2 mg/dL, existence of > 1 ureteral stone, hypotension and pain that could not be controlled with an analgesic
Interventions Treatment group:
  • doxazosin controlled release 4 mg/day until stone free or max 14 days

  • standard care: oral diclofenac sodium PRN, advised fluid intake that would provide urine output of at least 2 L/day


Control group: standard care only
SWL:
  • Lithotriptor: Siemens Lithoscope, Germany

  • Power setting: not reported, interval: 90/min

  • Number of shocks: max 3000, number of sessions: max 2; repeated if stone fragments > 6 mm

Outcomes Time to stone passage, number SWL sessions, stone free/failure, need for analgesics, need for additional procedure, steinstrasse
  • How measured: x‐ray KUB

  • Time point measured: day 1, 3, 5, 7, 10, 14


Subgroups: not reported
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: 7 July 2019 – general inquiry – Dr Ateş
Contact status: no reply to‐date
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomized into two groups according to a computer‐based randomization schedule."
Comment: appropriate method of random sequence generation.
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; 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: outcome assessors likely not blinded.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (major adverse events) High risk Comment: outcome assessors likely not blinded.
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "initially, a total of 90 patients were planned to be enrolled in the study, but eventually 79 patients completed the study."
Comment: 11 randomized participants with unclear group assignment not included in outcome analyses. With 35 (alpha‐blocker) and 44 (control arm) participants included, there was major concern that attrition primarily affected the intervention arm.
Selective reporting (reporting bias) Unclear risk Comment: no protocol available.
Other bias (additional SWL sessions) High risk Quote: "if, during the follow‐up visit after the first session, the stone was not influenced or the stone was fragmented into pieces equal to or larger than 6 mm, a second session of SWL was performed three days after the first procedure."
Comment: participants received > 1 SWL session.