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

Islam 2010.

Methods
  • Study design: RCT.

  • Study duration: July 2007 to December 2008.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Bangladesh.

  • Setting: NS.

  • Distal ureteral stones (juxtavesical tract and ureterovesical junction), 1 cm or smaller.

  • Number: treatment group 1: 33; treatment group 2: 33; control group: 32.

  • Mean age, years: treatment group 1: 46.6; treatment group 2: 47.4; control group: 42.8.

  • Sex, M/F: treatment group 1: 20/12; treatment group 2: 21/10; control group: 17/11.

  • Exclusion criteria: UTI; severe hydronephrosis; a solitary kidney; extra stone in the upper urinary system; underwent previous surgery for a urinary system stone; a non‐opaque stone; diseases such as diabetes or hypertension; pregnant women; those whose renal reserve was reduced by more than 50%.

Interventions Treatment group 1
  • Tamsulosin 0.4 mg daily.

  • Ciprofloxacin 500 mg, twice a day.

  • Diclofenac sodium for routine use during pain episodes.


Treatment group 2
  • Nifedipine 20 mg daily (slow‐release preparation).

  • Ciprofloxacin 500 mg, twice a day.

  • Diclofenac sodium for routine use during pain episodes.


Control group
  • Ciprofloxacin 500 mg, twice a day.

  • Diclofenac sodium for routine use during pain episodes.


All participants received 2500 mL hydration daily.
Outcomes
  • Stone passage rate.

  • Stone expulsion time.

  • Stone size.

  • Mean diclofenac sodium dosage.

  • Drug adverse events.

  • Hospitalisation.

Funding sources None stated.
Declarations of interest None stated.
Notes Follow‐up weekly with renal ultrasonography, X‐ray KUB, urinalysis, and serum creatinine measurements.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No quotes available.
Comment: randomisation 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 No quotes available.
Comment: Low percentage of loss to follow‐up in each group (< 5%); therefore risk of attrition bias was considered to be low.
Selective reporting (reporting bias) High risk No quotes available.
Comment: Mean diclofenac sodium dosage and drug adverse events were not described as outcome parameters in the Methods section; therefore risk of reporting bias was considered to be high.
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.