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

Doluoglu 2015.

Methods
  • Study design: RCT.

  • Study duration: September 2013 to October 2014.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Patients with stone measuring ≤ 6 mm in the distal ureter; evaluated with KUB, US, and NCCT in selected patients.

  • Number: treatment group: 27; control group: 30.

  • Mean age, SD, years: treatment group: 39.3 ± 8.1; control group: 34 ± 10.4.

  • Sex, M/F: treatment group: 27/0; control group: 30/0.

  • Exclusion criteria: Aged < 18 years; did not have an active sexual partner; described erectile dysfunction; diabetes mellitus; a stone measuring > 6 mm; a stone located in the mid‐ureter or proximal ureter (above iliac vessels); non‐opaque or multiple stones; urinary tract infection; severe hydronephrosis; history of stone passage or previous endoscopic or open ureteral surgery; high serum creatinine levels; previous use of a‐1‐adrenergic receptor or calcium channel blockers.

Interventions Treatment group
  • Tamsulosin 0.4 mg once daily.


Control group
  • All groups received 75 mg diclofenac injections when needed. Buscopan 10 mg twice daily orally.

Outcomes
  • Stone passage rate.

  • Time to stone passage.

  • Number of pain episodes.

  • Need for diclofenac injections.

  • Number of sexual intercourse attempts.

Funding sources None.
Declarations of interest None.
Notes Follow‐up visits on a weekly basis with urine analysis, plain X‐ray KUB, and abdominal ultrasonography.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “The patients were randomly divided into 3 groups with the random number table envelope method.”
Comment: This method of random sequence generation was considered to have low risk of bias.
Allocation concealment (selection bias) Low risk Quote: “The names of the groups were written on small papers with the same size, they were folded, put in an envelope, and drawn by the patients.“
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 quote available. Participants were blinded, and blinding of doctors was not described.
Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “On follow‐up, plain urinary tract x‐ray images of the patients were seen and analyzed by an urologist (MFK) blinded to the group of the patients.“
Comment: Risk of detection bias was considered to be low.
Incomplete outcome data (attrition bias) 
 All outcomes High risk No quote available. 13/57 participants lost to follow‐up equally distributed among control and treatment groups.
Comment: Owing to a reasonable number of participants lost to follow‐up (> 20%), risk of attrition bias was considered to be high.
Selective reporting (reporting bias) High risk No quote available. No number of pain episodes described in the Results section (although this was a secondary outcome measurement). Furthermore adverse effects were predefined in Methods section and were not described in Results section.
Comment: Owing to inconsistent reporting, 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.