Eryildirim 2016.
Study characteristics | ||
Methods |
Study design: parallel RCT Number of centers/setting: presumed single center/not reported Country: Turkey Dates of the study: January 2015 to December 2015 |
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Participants |
Total number of participants randomized: 80
Age (mean, years):
Sex (M/F): not reported Stone location: upper ureteral Stone size: not reported Inclusion criteria: > 18 years, treated with SWL for 5–10 mm single radio‐opaque upper ureteral stones (above iliac vessels) Exclusion criteria: people with multiple stones, previous stone related procedures, obstruction, stent placement, auxiliary procedures, congenital anomalies, active UTI, pregnancy or renal insufficiency |
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Interventions |
Treatment group:
Control group: standard care only SWL:
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Outcomes |
Primary: HRQoL
Secondary: stone free rate, analgesic requirement, number renal colic attacks and emergency room visits Subgroups: not reported |
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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: 7 July 2019 – general inquiry to Dr Eryildirim 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: "a simple method by generating a random digit (0–60) was used." Comment: appropriate method of random sequence generation was used. |
Allocation concealment (selection bias) | High risk | Quote: "even numbers were used for cases undergoing SWL without MET and odd numbers were used for cases undergoing SWL procedure followed by MET initiation." Comment: allocation not concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no placebo use described; 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 blinding of outcome assessors described; likely not blinded. |
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (major adverse events) | High risk | Comment: no blinding of outcome assessors described; likely not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "following the exclusion of cases requiring DJ stent placement (a total of 12 cases; seven cases in group 1 and five cases in group 2)." Comment: 10–19% of randomized participants not included in analyses of reported outcomes. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | Unclear risk | Comment: unclear whether > 1 SWL session was administered. |