Skip to main content
. 2020 Nov 12;2020(11):CD013393. doi: 10.1002/14651858.CD013393.pub2

Kang 2009.

Study characteristics
Methods Study design: prospective, multicenter RCT
Number of centers/setting: multicenter/outpatients
Country: South Korea
Dates of the study: July 2007 to December 2007
Participants Total number of participants randomized: 207
  • tamsulosin + diclofenac group: 115

  • diclofenac only group: 92


Age (mean, years):
  • tamsulosin + diclofenac group: 51.08 (SD 12.77)

  • diclofenac only group: 47.6 (SD 13.59)


Sex (M/F):
  • tamsulosin + diclofenac group: 73/42

  • diclofenac only group: 59/33


Stone location:
  • tamsulosin + diclofenac group: 18 renal/50 upper ureteral/47 lower ureteral

  • diclofenac only group: 19 renal/34 upper ureteral/39 lower ureteral


Stone size: not reported
Inclusion criteria: people with ≥ 4 mm renal or ureteral stone with acute pain
Exclusion criteria: non‐functioning kidney, severe pain which is not relieved by conservative treatment, multiple stones, severe hydronephrosis, pregnancy, serum creatinine ≥ 2.5 mg/dL, history of ureteral operation, ureteral stricture and ureteral stent placement
Interventions Treatment group:
  • tamsulosin 0.2 mg once per day for 1 week

  • diclofenac 100 mg once per day for 1 week

  • standard care: not reported


Control group: diclofenac 100 mg once per day for 1 week
SWL:
  • Lithotriptor: Compact Delta II (Dornier Medtech, Germany); E‐3000 (Medispec, USA); Sonolith Praktis (EDAP TMS, Germany)

  • Power setting: not reported, interval: not reported

  • Number of shocks: not reported, number of sessions: 1

Outcomes Stone clearance rate, pain change after treatment, distance of stone migration (if stone was not passed), stone clearance rate according to SWL machines
  • How measured: pain: VAS; other outcomes: not reported

  • Time point measured: 1 week


Subgroups: expulsion rate according to SWL machines
Funding sources Not reported
Declarations of interest Not reported
Notes Language of publication: Korean
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 Quote: "prospective randomized study."
Allocation concealment (selection bias) Unclear risk No information given.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information given.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (stone clearance, time to stone clearance) Unclear risk No information given.
Blinding of outcome assessment (detection bias)
Investigator assessed; susceptible (major adverse events) Unclear risk No information given.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants were included in the analysis.
Selective reporting (reporting bias) Unclear risk No protocol available
Other bias (additional SWL sessions) Unclear risk Comment: number of SWL sessions unclear.