Cakıroglu 2013.
Study characteristics | ||
Methods |
Study design: parallel RCT Number of centers/setting: single center/hospital Country: Turkey Dates of the study: June 2008 to July 2011 |
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Participants |
Total number of participants randomized: 123
Age (mean, years):
Sex (M/F):
Stone location: ureteral Stone size (mean, mm):
Inclusion criteria: people with a solitary ureteral stone ≥ 6 mm up to 15 mm and located in the upper, middle or lower ureter underwent SWL Exclusion criteria: ages ≤ 18 years; weight < 50 kg or > 100 kg; severe skeletal malformation; pregnancy; aortic or renal artery aneurysm, or both; history of drug or alcohol abuse; long‐term use of drugs such as antidepressants, histamine blockers and anxiolytics; allergy study medications; concomitant treatment with calcium antagonists or alpha1‐blocker, or both; concomitant renal stones; previous unsuccessful attempts at SWL; elevated serum creatinine (> 2 mg/dL); UTI; diabetes; peptic ulcers; history of spontaneous stone expulsion; hypotension; coagulopathy; urinary congenital anomalies; or previous nephroureteral surgery |
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Interventions |
Treatment group:
Control group: standard medical therapy alone SWL:
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Outcomes | Not reported Subgroups: stone location |
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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: 7 July 2019 – general inquiry to Drs Cakiroglu and Sinanoglu: Contact status: no reply to‐date |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "using the coin toss method." Comment: method of sequence generation described and appropriate. |
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: outcome assessors likely not blinded. |
Blinding of outcome assessment (detection bias) Investigator assessed; susceptible (major adverse events) | High risk | Comment: outcome assessors likely not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "the data for the 123 patients who completed follow‐up without dropping out met the criteria." Comment: description implied that number randomized was greater than the number included in analysis; no further details provided. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. |
Other bias (additional SWL sessions) | High risk | Comment: Table 1 refers to > 1 SWL per participant. |