Mohamed 2013.
Study characteristics | ||
Methods |
Study design: prospective RCT Number of centers/setting: single center/outpatient Country: Egypt Dates of the study: July 2010 to May 2012 |
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Participants |
Total number of participants randomized: 130
Age (mean, years):
Sex (M/F):
Stone location:
Stone size (mean, mm): not reported Inclusion criteria: solitary ureteric stone 5–15 mm diameter Exclusion criteria: aged < 15 years, pregnancy, uncontrolled UTI, multiple ureteric stones, presence of ureteric stricture distal to stone, previous unsuccessful ESWL, concomitant use of calcium‐channel blockers or alpha‐blockers, uncorrected coagulation profile, severe vertebral malformation, morbid obesity, severe cardiopulmonary disorders, elevated serum creatinine (> 2 mg/dL), high grade hydronephrosis, diabetes mellitus, bladder outlet obstruction, neuropathic bladder, gastric ulcer disease (to avoid exacerbation of ulcer disease by analgesics) |
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Interventions |
Treatment group:
Control group: standard medical therapy alone SWL:
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Outcomes |
Primary: stone clearance, failure, clinically significant residual fragments, stone free, complications, auxiliary procedures
Secondary: expulsion time, median number of ESWL sessions, steinstrasse, cumulative diclofenac dose Subgroups: stone location, stone size |
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Funding sources | None | |
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) | Low risk | Quote: "the 130 and 30 patients were randomized into two equal groups using a computer program." Comment: appropriate method of random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not described. |
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: no mention of placebo; outcome assessors likely not blinded. |
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (major adverse events) | High risk | Comment: no mention of placebo; outcome assessors likely not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: based on flow diagram, all randomized participants included in analyses of reported outcomes. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | Unclear risk | Comment: several sessions; unclear how many participants received how many SWL sessions. |