Gameel 2013.

Study characteristics
Methods	Study design: single‐blind, parallel‐group randomized controlled trial Setting/country: Urology Department, Tanta University Hospitals, Tanta, Egypt Dates study conducted: November 2009 to January 2012
Participants	Inclusion criteria: Men with PE for > 1 year and who had an IELT of < 2 minutes in > 75% of episodes of vaginal sexual intercourse over a 2‐week period Exclusion criteria: IIEF‐5 score of < 22 Unstable relationship with the partner Drug abuse Medical conditions such as diabetes mellitus, urogenital diseases, hepatic or renal impairments Receiving medication for psychiatric problems Total number of participants randomized: 150 Total length of study: 4 weeks Group 1 (paroxetine): Number of participants randomized: 30 Age: NR Baseline IELT (mean): 69.6 (SD 28.1) seconds Group 2 (placebo): Number of participants randomized: 30 Age: NR Baseline IELT (mean): 61.3 (SD 30.5) seconds
Interventions	Group 1: paroxetine 20 mg on‐demand + lubricating jelly Group 2: placebo on‐demand + lubricating jelly
Outcomes	Primary outcomes: IELT How measured: reported Time points measured: 0, 4 weeks Secondary outcomes: Sexual satisfaction How measured: participant‐reported using sexual satisfaction scale (0–5) Time points measured: 0, 4 weeks Safety outcomes: Adverse effects How measured: reported by participants Time point measured: 4 weeks
Funding sources	None
Declarations of interest	None
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence created from "shuffling coded cards."
Allocation concealment (selection bias)	Unclear risk	Methods not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel not blinded. Quote: "single blind study."
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Appropriate use of placebo, participants likely blinded. Quote: "Group 5 was a placebo arm and received oral multivitamin pills 1–4 h before intercourse. To ensure that patients were unaware of the drug used, those receiving oral medication were also given local penile lubricating jelly before intercourse, whilst group 4 was also given oral multivitamin pills 1–4 h before intercourse."
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	High risk	Assessors unlikely blinded. Quote: "single blind study."
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	Low risk	Low proportion of missing data (28/30 (94%) in SSRI arm and 27/30 (90%) in placebo arm included in final analysis).
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Low risk	No additional sources of bias identified.