Janane 2014.
Study characteristics | ||
Methods |
Study design: placebo controlled RCT Number of centers/setting: presumed single center/not reported Country: Morocco Dates of the study: January 2008 to December 2012 |
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Participants |
Total number of participants randomized: 356
Age (mean, years):
Sex (M/F):
Stone location:
Stone size (mean, mm):
Inclusion criteria: people with lower ureteral stones undergoing ESWL Exclusion criteria: UTI, multiple stones, severe hydronephrosis, solitary kidney, congenital urinary anomalies or previous ureteral surgery, severe obesity, pregnancy, lactation or previous treatment with alpha‐blockers |
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Interventions |
Treatment group:
Control group: placebo SWL:
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Outcomes | Stone free rate, stone expulsion time, ureteral colic
Subgroups: stone size |
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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: none Contact status: N/A |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "simple random allocation." Comment: method of random sequence generation unclear. |
Allocation concealment (selection bias) | Unclear risk | Quote: "simple random allocation." Comment: allocation concealment not addressed. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "placebo‐controlled medical treatment." Comment: no additional information provided to support that participants were adequately blinded. |
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (stone clearance, time to stone clearance) | Unclear risk | Comment: blinding of outcome assessors not addressed. |
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (major adverse events) | Unclear risk | Comment: blinding of outcome assessors not addressed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: unable to assess what proportion of randomized participants were included in outcome analyses. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | Low risk | Quote: "after single ESWL session…" Comment: single SWL session. |