Singh 2011a.
Study characteristics | ||
Methods |
Study design: prospective RCT Number of centers/setting: single center/outpatient Country: India Dates of the study: January 2006 to June 2008 |
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Participants |
Total number of participants randomized: 120
Age (mean, years):
Sex (M/F):
Stone location: lower ureter Stone size: not reported Inclusion criteria: consecutive patients ages > 18 years with symptomatic, unilateral, solitary lower ureteric calculus confirmed by abdominal x‐ray and sonography KUB 4–12 mm in major axis Exclusion criteria: active UTI, fever, acute renal failure, chronic renal failure, history of urinary tract surgery or endoscopic treatment, uncorrected distal obstruction, severe hydronephrosis, pregnancy, concomitant treatment with alpha‐blockers, calcium channel blockers, steroids, morbid obesity, history of previous failed ESWL |
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Interventions |
Treatment group:
Control group: control SWL:
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Outcomes | Doses of analgesic required, stone free rate, clearance time, any complications
Subgroups: stone size (4–7 mm, 8–12 mm) |
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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 | Comment: method of random sequence generation unclear. |
Allocation concealment (selection bias) | Unclear risk | Comment: unclear whether allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open label study." Comment: 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: 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: "one patient from control group was withdrawn from the study due to severe colic and underwent ureteroscopy." Comment: low loss‐to‐follow‐up rate. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | Low risk | Quote: "single session of ESWL." Comment: 1 SWL session was administered. |