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

Cha 2012.

Methods
  • Study design: RCT.

  • Study duration: September 2008 and June 2011.

  • Follow‐up/Treatment duration: 28 days.

Participants
  • Country: Korea.

  • Setting: single centre.

  • One single lower ureteral stone, measuring 4‐10 mm.

  • Number: treatment group 1: 41; treatment group 2: 30; treatment group 3: 36; control group: 34.

  • Mean age ± SD, years: treatment group 1: 45.07 ± 13.77; treatment group 2: 45.50 ± 11.09; treatment group 3: 42.33 ± 12.58; control group: 43.65 ± 10.87.

  • Sex, M/F: treatment group 1: 31/10; treatment group 2: 20/10; treatment group 3: 25/11; control group: 18/16.

  • Exclusion criteria: UTI; moderate or severe hydronephrosis; hypotension; single kidney; bilateral ureteral stones; history of previous surgery on the ipsilateral ureter; currently taking an alpha‐blocker, steroid, or calcium channel blocker; renal insufficiency; < 18 years of age; pregnant or lactating women.

Interventions All participants received trospium chloride (50 mg 3 times daily). All participants received initial treatment of 90 mg diclofenac by intramuscular injection and 5 mg cimetropium bromide by intravenous injection, with a second dose after 30 minutes or 1 hour if necessary.
Treatment group 1
  • Tamsulosin 0.2 mg once daily.


Treatment group 2
  • Tamsulosin 0.2 mg twice daily.


Treatment group 3
  • Alfuzosin 10 mg once daily.


Control group
  • Solely trospium chloride.

Outcomes
  • Stone size.

  • Stone expulsion rate.

  • Stone expulsion time.

  • Drug side effects.

Funding sources None.
Declarations of interest None.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “The randomization list was generated by using the permuted block method.”
Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias) Low risk Quote: “... was concealed from the patient‐enrolling investigators (confined with a doctor assisting in the procedure but not participating in the study).”
Comment: This method of allocation concealment was considered to have low 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 No quotes available.
Comment: All participants completed the study; 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 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.