Qadri 2014.
Study characteristics | ||
Methods |
Study design: parallel RCT Number of centers/setting: single center/not reported Country: Pakistan Dates of the study: July 2010 to December 2010 |
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Participants |
Total number of participants randomized: 120
Age (mean, years):
Sex (M/F):
Stone location:
Stone size (mean, mm):
Inclusion criteria: people with single radio‐opaque renal stone (0.5–2.0 cm) Exclusion criteria: age extremes (18–60 years), recent open or endoscopic surgical intervention, presence of ureteral stent, radiolucent calculus, past unsuccessful ESWL, renal impairment (serum creatinine level above normal range), UTI, receiving calcium channel blocker or alpha‐blocker and corticosteroids, congenital urinary anomalies, severe vertebral malformation |
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Interventions |
Treatment group:
Control group: control SWL:
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Outcomes | Stone clearance rate, time to stone clearance (in weeks), mean intensity of pain, incidence of steinstrasse formation and incidence of auxiliary procedure required
Subgroups: stone location, stone size, gender, age |
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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: 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: "randomly assigned by envelope method to either standard therapy or alpha blocker." Comment: appropriate method of sequence generation |
Allocation concealment (selection bias) | Unclear risk | Comment: unclear whether allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "randomized non‐placebo‐controlled study." Comment: open label study; participants 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: investigators likely not blinded in this open label study. |
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (major adverse events) | High risk | Comment: investigators likely not blinded in this open label study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "none of them 120 patients included in the study dropped out and all were followed till the end of the study." Comment: no attrition. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | High risk | Quote: "the subsequent sessions of SWL needed were given after every two weeks." Comment: multiple SWL sessions; unclear how many per group. |