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

El Said 2015.

Methods
  • Study design: prospective RCT.

  • Study duration: NS.

  • Follow‐up/treatment duration: 4 weeks.

Participants
  • Country: Egypt.

  • Setting: single centre, outpatient clinic.

  • Patients with distal ureteral calculi.

  • Number: treatment group: 28; control group: 26.

  • Mean age ± SD, years: treatment group: 32.8 ± 9.5; control group: 32.1 ± 9.2.

  • Sex, M/F: treatment group: 18/10; control group: 16/10.

  • Exclusion criteria: UTI; ureteral strictures; renal impairment; solitary functioning kidney; diabetes mellitus; hepatic insufficiency; severe hydronephrosis; hypotension; pregnancy; lactation; sensitivity to alpha‐blockers; use of alpha‐1‐blockers, beta‐blockers, sildenafil, ketoconazole, itraconazole, ritonavir.

Interventions Treatment group (group 2)
  • Alfuzosin 5 mg twice daily.

  • Diclofenac 75 mg IM on demand.


Control group (group 1)
  • Diclofenac 75 mg IM on demand.


All participants were asked to drink > 2 L of water daily and received diclofenac 75 mg IM on demand.
Outcomes
  • Stone passage rate.

  • Number of pain episodes.

  • Pain level.

  • Analgesic consumption.

  • Number of hospital revisits.

  • Drug adverse events.

  • Complications.

Funding sources Welcome Trust: Howard Hughes Medical Institute and others.
Declarations of interest None.
Notes Article 2015.
Conference abstract 2014.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “randomly assigned to either the control group or the alfuzosin group based on a computer‐generated random table.”
Comment: This method of random sequence generation was considered to have low risk of bias.
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 High risk Quote: “This was a prospective, randomized, open–label, controlled study.”
Comment: open label trial; therefore risk of performance bias was considered to be high.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: “This was a prospective, randomized, open–label, controlled study.“
Comment: open label trial; therefore risk of detection bias was considered to be high.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No quote available.
Comment: All participants were included in the analysis; 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.