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. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Cervenakov 2002.

Methods
  • Study design: DB RCT.

  • Study duration: June 1999 to January 2002.

  • Follow‐up/Treatment duration: probably 7 days.

Participants
  • Country: Slovakia.

  • Setting: inpatients.

  • Patients, 17‐76 years, with X‐ray‐verified lower urinary tract stones < 10 mm.

  • Number: treatment group: 51; control group: 53 enrolled/51 evaluated.

  • Age range, years: treatment group: 18‐76; control group: 17‐74.

  • Sex, M/F: treatment group: 32/19; control group: 33/18.

  • Exclusion criteria: pregnant women; new and decompensated diabetes mellitus; febrile state; advanced ureterohydronephroses; UTI; grave polyvalent allergies.

Interventions Treatment group
  • Tamsulosin 0.4 mg.

  • Standard therapy.


Control group
  • Standard therapy

    • 1 amp Tramal 50 mg – analgeticum + 1 amp diazepam 5 mg – anxiolyticum in 150 mL physiological saline infusion solution applied IV.

  • These participants were also given the following per os: 3 × 2 tablets Yellon per 20 mg – antiexudativum and non‐steroid antirheumatic Veral, 3 times daily per 50 mg.


All participants were made to keep a drinking regimen of at least 2.5 L of water or weak tea daily.
Outcomes
  • Stone expulsion rate.

Funding sources None stated.
Declarations of interest None stated.
Notes Study authors stated the study model was a double blind RCT but described no blinding.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "we have applied a double blind randomized study."
Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.
Allocation concealment (selection bias) Unclear risk No quotes available. Insufficient information to permit judgement.
Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No quotes available. No blinding described.
Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No quotes available. No blinding of outcome assessments described.
Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "As two pts. were excluded from group “A” because during treatment they developed acute obstruction pyelonephritis, both groups consisted of a rather unusual identical number of experimental and standardly treated pts. (51)."
Comment: In the light of the small number of participants lost to follow‐up, risk of attrition bias was stated as low.
Selective reporting (reporting bias) Low risk No quotes available. Expected outcomes were reported according to objectives.
Comment: Risk of reporting bias was therefore considered to be low.
Other bias Low risk No quotes available. Study appears to be free of other sources of bias.
Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.