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

Bayraktar 2017.

Methods
  • Study design: prospective RCT.

  • Study duration: December 2015 and May 2017.

  • Follow‐up/Treatment duration: 4 weeks.

Participants
  • Country: Turkey.

  • Setting: single centre.

  • Married male patients over the age of 18 years with opaque distal ureteral stones measuring 5–10 mm.

  • Number: treatment group 1: 60; sexual intercourse group 2: 66; control group: 64.

  • Mean age ± SD, years: group 1: 34.4 ± 13.5; group 2: 38.66 ± 14.1; group 3: 36.92 ± 12.4.

  • Sex, M/F: only male patients.

  • Exclusion criteria: proximal or intermediate ureter stones (stones on the ureter‐iliac artery cross); stones < 5 mm; stones ≥ 10 mm; multiple ureter stones; < 18 years of age; urinary infection; fever; renal insufficiency; high creatinine level; pregnancy; severe hydroureteronephrosis; endoscopic or open ureteral surgery history; ureteral stenosis; vesicoureteral reflux; neurogenic bladder; unmarried patients; erectile dysfunction; more than 1 sexual intercourse and masturbation statement per week for group 1 and group 3; fewer than 3 sexual intercourse statements per week for group 2.

Interventions Treatment group 1
  • Tamsulosin 0.4 mg once daily.


Treatment group 2
  • Sexual intercourse.


Control group
  • As standard medical therapy, all participants were recommended daily intake of liquids to urinate at least 1.5–2 L, and 75 mg of diclofenac injected when needed for pain.

Outcomes
  • Number of pain.

  • Need for pain killer injection.

  • Number of masturbation and sexual intercourse attempts during follow‐up.

  • Stone expulsion rate.

Funding sources None.
Declarations of interest None.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "randomly divided into three groups according to the order of arrival (1:1:1 ratio)."
Comment: This method of random sequence generation was considered to have high 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 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 Low risk Quote: "all tomography and direct urinary system graphy of the patients were analyzed and confirmed by a urologist blinded to the group of the patients."
Comment: Risk of detection bias was considered to be low.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "A total of 13 patients, 6 in group 1, 4 in group 2, and 3 in group 3, were excluded from the study because they were lost in follow‐up. 5 patients in group 1 and 3 patients in group 3 were also excluded from the study because they declared more than one sexual intercourse or masturbation per week."
Comment: 21/211 participants were lost to follow‐up and were equally divided over the 3 groups; 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 High risk No quotes available. Only males were included in the study.
Comment: Potential selection bias; therefore high risk of other bias.