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. 2021 Mar 21;2021(3):CD012799. doi: 10.1002/14651858.CD012799.pub2

Na 1996.

Study characteristics
Methods Study design: randomized controlled, parallel‐group trial
Setting/country: Outpatient/Department of Urology, Korea University College of Medicine, Seoul, South Korea
Dates study conducted: NR
Participants Inclusion criteria:

  • Healthy men age ≥ 20 years, IELT ≤ 1 minute (over 50% of intercourse)


Exclusion criteria:

  • NR


Number of participants randomized: 40
Group 1 (sertraline):

  • Number of participants randomized: 20

  • Age: NR

  • Baseline IELT: NR


Group 2 (placebo):

  • Number of participants randomized: 20

  • Age: NR

  • Baseline IELT: NR
Interventions Group 1: sertraline 50 mg at night that could be titrated up to 100 mg daily
Group 2: digestive medicine with same manner of intervention
Outcomes Primary outcomes:

  • IELT/penile rigidity/vaginal penetration

  • How measured: stopwatch/NR/NR

  • Time points measured: at baseline, 3, 6 weeks


Safety outcomes:

  • Adverse effects

  • How measured: NR

  • Time point measured: likely cumulative
Funding sources NR
Declarations of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not described.
Allocation concealment (selection bias) Unclear risk Methods not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Study described as double‐blind; no further information.
Blinding of outcome assessment (detection bias)
Participant‐reported outcomes Unclear risk No information.
Blinding of outcome assessment (detection bias)
Investigator‐assessed outcomes Unclear risk No information.
Blinding of outcome assessment (detection bias)
IELT Low risk Objective measurement that was unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias)
All outcomes High risk 12/20 in sertraline arm and 8/20 participants in placebo arm were included in analysis.
Selective reporting (reporting bias) Unclear risk No protocol available and review outcomes were not clearly defined in method section.
Other bias Low risk No additional sources of bias identified.