Skip to main content
. 2018 Apr 5;2018(4):CD008509. doi: 10.1002/14651858.CD008509.pub3

Hermanns 2009.

Methods
  • Study design: :double‐blind RCT.

  • Study duration: September 2006 to September 2008.

  • Follow‐up/Treatment duration: 21 days.

Participants
  • Country: Switzerland.

  • Setting: outpatient, single centre.

  • Patients ≥ 18 years with single ureteral stone ≤ 7 mm below the common iliac vessels, as assessed on NCCT.

  • Number: treatment group: 50; control group: 50.

  • Median age, years (IQR): treatment group: 36 (30–44); control group: 41 (33–54).

  • Sex, M/F: treatment group: 39/6; control group: 36/9.

  • Exclusion criteria: presence of multiple ureteral stones; renal insufficiency (eGFR < 60 mL/min/1.73 m²); UTI; a solitary kidney; pregnancy; history of ureteral surgery or previous endoscopic procedures; hypersensitivity to tamsulosin or current alpha‐blocker, calcium antagonist, or corticosteroid medication.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.


Control group
  • Placebo.

Outcomes
  • Stone expulsion rate.

  • Time to stone passage.

  • Required total amount of analgesic.

  • Reported maximum daily pain score until stone expulsion.

  • Intervention rate.

  • Safety of therapy.

Funding sources None.
Declarations of interest None.
Notes Sample size calculated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Enrolled patients underwent randomisation in a 1:1 fashion in blocks of 10 to receive either a daily single dose of tamsulosin (0.4 mg) or placebo. The sequence of randomisation was computer generated and was performed by the university hospital pharmacy using DatInf Randlist software v.1.0 (DatInf GmbH, Tübingen, Germany)."
Comment: This method of random sequence generation was considered to be at low risk of bias.
Allocation concealment (selection bias) Low risk Quote: "Randomisation data were kept strictly confidential in sealed envelopes, accessible only to the primary and senior investigator."
Comment: This method of allocation concealment was considered to have low risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The patient, the attending urologist were not aware of study arm assignments until the final assessment of outcome."
Comment: double‐blind.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Personnel responsible for outcome assessments were blinded."
Comment: double‐blind; therefore low risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Patients were included in the final analysis on an intention‐to‐treat basis. Patients who experienced stone expulsion before first medication, who withdrew their consent, or who were lost to follow‐up were excluded from the analysis."
Comment: missing outcome data and losses to follow‐up balanced in numbers across both groups; therefore risk of attrition bias was considered to be 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.