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

Athanasios 2007.

Study characteristics
Methods Study design: parallel‐group, randomized controlled trial
Setting/country: Urology Department, ELPIS Hospital, Volos, Greece
Dates study conducted: NR
Participants Inclusion criteria:

  • Married men diagnosed with PE


Exclusion criteria:

  • ED

  • Severe physical illness

  • History of alcohol or any drug abuse

  • Did not require psychotropic medication during the last 3 months.


Number of participants randomized: 20
Study length: 12 months
Group 1 (duloxetine):

  • Number of participants randomized: 10

  • Age (mean): 31.35 (SD 8.23) years

  • Baseline IELT: 38.21 (16.45) seconds


Group 2 (placebo):

  • Number of participants randomized: 10

  • Age (mean): 32.65 (SD 7.49) years

  • Baseline IELT: 34.79 (18.35) seconds
Interventions Group 1: duloxetine 20 mg daily for 1 week followed by 40 mg daily
Group 2: placebo daily
Outcomes Primary outcome:

  • IELT

  • How measured: using a chronometer

  • Time point measured: NR


Secondary outcome:

  • CGI

  • How measured: CGI questionnaire at interview

  • Time points measured: 0, 2, 4, 6, 8, 10, 12 weeks


Safety outcome:

  • Adverse effects

  • How measured: reported

  • Time points measured: anytime
Funding sources NR
Declarations of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Did not explicitly state that personnel were blinded, only "double blind."
Blinding of outcome assessment (detection bias)
Participant‐reported outcomes Low risk Participants appeared to be appropriately blinded.
Blinding of outcome assessment (detection bias)
Investigator‐assessed outcomes Unclear risk No explicit description as to how these outcomes were assessed.
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 Unclear risk Unclear how many participants were included in analyses.
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk No additional sources of bias identified.