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. 2020 Nov 12;2020(11):CD013393. doi: 10.1002/14651858.CD013393.pub2

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
Participants Total number of participants randomized: 123
  • tamsulosin group: not reported

  • standard medical therapy alone group: not reported


Age (mean, years):
  • tamsulosin group: 44.66 (SD 13.25)

  • standard medical therapy alone group: 42.19 (SD 13.17)


Sex (M/F):
  • tamsulosin group: 47/12

  • standard medical therapy alone group: 51/13


Stone location: ureteral
Stone size (mean, mm):
  • tamsulosin group: 11.4 (SD 3.01)

  • standard medical therapy alone group: 42.19 (SD 13.17)


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
Interventions Treatment group:
  • tamsulosin 0.4 mg/day for max 28 days or until an alternative treatment was started

  • standard care: diclofenac 75 mg intramuscularly PRN, pantoprazole 40 mg/day, after discharge drink 2 L water daily


Control group: standard medical therapy alone
SWL:
  • Lithotriptor: Storz Medical AG Modulith Slk (Tӓgerwilen, Switzerland) with both ultrasonic and fluoroscopic focusing

  • Power setting: 18.5 kV (range 6–19), interval: not reported

  • Number of shocks: 3140 mean (range 2700–3600), number of sessions: 1

Outcomes Not reported
Subgroups: stone location
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
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.