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 |
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Participants |
Total number of participants randomized: 90
Age (mean, years):
Sex (M/F):
Stone location: upper ureteral Stone size (mean, mm):
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 |
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Interventions |
Treatment group:
Control group: standard care only SWL:
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Outcomes | Time to stone passage, number SWL sessions, stone free/failure, need for analgesics, need for additional procedure, steinstrasse
Subgroups: not reported |
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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 |
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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. |