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

Zhou 2011.

Methods
  • Study design: RCT.

  • Study duration: December 2008 to September 2010.

  • Follow‐up/Treatment duration: 2 weeks.

Participants
  • Country: China.

  • Setting: single centre.

  • Patients with a distal ureteral stone (< 10 to > 4 mm).

  • Number: treatment group 1: 43; treatment group 2: 45; control group: 43.

  • Mean age ± SD, years: treatment group 1: 33.73 ± 8.84; treatment group 2: 34.42 ± 8.64; control group: 34.79 ± 9.63.

  • Sex, M/F: treatment group 1: 25/18; treatment group 2: 27/18; control group: 27/16.

  • Exclusion criteria: multiple stones; severe incarcerated stones; history of distal ureteral surgery; history of spontaneous stone expulsion; renal colic for longer than 24 hours; urinary tract infection; severe hydronephrosis; voiding dysfunction; hypotension; cardiovascular and cerebrovascular diseases; hepatic and renal dysfunction; pregnancy and diabetes; history of hypersensitivity to naftopidil; receiving treatment with cardiovascular drugs, alpha‐receptor antagonists, or calcium antagonists.

Interventions Treatment group 1
  • Naftopidil 10 mg once daily.


Treatment group 2
  • Tamsulosin 0.4 mg once daily.


Control group
  • Watchful waiting.


Both groups were also advised to drink at least 2 L of fluids daily. An indomethacin suppository was recommended for routine use during pain episodes.
Outcomes
  • Stone expulsion rate.

  • Stone expulsion time.

  • Number of pain episodes.

  • Requirements for pain medication.

  • Side effects of naftopidil.

Funding sources None stated.
Declarations of interest None.
Notes Follow‐up weekly with KUB and ultrasonography.
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: no participants lost to follow‐up; 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.

AKI: acute kidney injury; CCB: calcium channel blocker; CKD: chronic kidney disease; CT: computed tomography; DB: double‐blind; ED: emergency department; eGFR: estimated glomerular filtration rate; ESWL: extracorporeal shockwave lithotripsy; EuroQOL: EuroQOL Group quaity of life questionnaire; GFR: glomerular filtration rate: HRQOL: health‐related quality of life; HTA: health technology assessment; HU: Hounsfield unit; IM: intramuscular; IQR: interquartile ratio; IV: intravenous; IVU: Intravenous urography; KUB: kidney, ureter, and bladder plain x‐ray; MET: medical expulsive therapy; NCCT: non‐contrast computed tomography; NHS: National Health Service; NIHR: National Institute for Health Research; NS: not stated; NSAID: non‐steroidal anti‐inflammatory drug; PDE5: phosphodiesterase type 5; QALY: quality‐adjusted life‐year; QOL: quality of life; RCT: randomised controlled trial; SCr: serum creatinine; SD: standard deviation; SWL: shockwave lithotripsy; US: ultrasound; UTI: urinary tract infection; VAS: visual analogue scale; WBC: white blood cell.