Micali 2007.
Study characteristics | ||
Methods |
Study design: parallel RCT Number of centers/setting: not reported Country: Italy Dates of the study: January 2003 to March 2005 |
|
Participants |
Total number of participants randomized: 113
Age (mean, years):
Sex (M/F):
Stone location:
Stone size (mean, mm):
Inclusion criteria: people with radiopaque or radiolucent ureteral lithiasis selected for ESWL treatment Exclusion criteria: signs and symptoms of UTI, pregnancy, multiple stones, severe hydronephrosis, hypotension, gastric ulcer disease, obesity, history of spontaneous stone expulsion, previous ureteral surgery |
|
Interventions |
Treatment group:
Control group: standard care only (lower ureteral stones) Comparator group: nifedipine 30 mg/day orally for 14 days Control 2 group: standard care only (mid‐ureteral stones) SWL:
|
|
Outcomes | Stone free condition: complete absence of any stone or the presence of residual fragments < 3 mm in diameter
Subgroups: stone location (upper, middle, lower ureteral), follow‐up stage (1, 2 months) |
|
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 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomization not specified but confirmed by authors; method of random sequence generation not specified. |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not addressed. |
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; 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 | Quote: "All the patients completed the study." Comment: based on reported denominators, all randomized participants appear to have been included in analyses of all reported outcomes. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | Low risk | Quote: "all patients underwent a single session of ESWL." Comment: single SWL session; additional treatments accounted for as auxiliary treatments. |