The HelpED study: agreement and impact of the erection hardness score on sexual function and psychosocial outcomes in men with erectile dysfunction and their partners.

INTRODUCTION: The HelpED study assessed men with erectile dysfunction (ED) treated with a phosphodiesterase type 5 (PDE5) inhibitor and their female partner in a community setting. AIM: To examine agreement in Erection Hardness Score (EHS) in patients and partners; to assess impact of EHS changes on other sexual health outcomes and behaviors. METHODS: At baseline and follow-up 2 to 4 months later, men in a stable heterosexual relationship who had newly diagnosed or untreated ED (≥6 months) completed the single-item EHS, the International Index of Erectile Function questions 4 and 5 (assessing erection maintenance), the Self-Esteem And Relationship (SEAR) questionnaire, and a modified Quality of Life domain of the Sexual Life Quality Questionnaire (mSLQQ-QOL). Partners completed the EHS, Female Sexual Function Index, and the mSLQQ-QOL. MAIN OUTCOME MEASURES: EHS agreement assessed by Cohen weighted kappa coefficient, associations between change in EHS and change in measures of sexual function and quality of life; outcomes stratified by patient age (≤55 years vs. >55 years). RESULTS: Questionnaires were completed by 447 men (64% aged 51-70 years) and 253 partners (52% aged 46-60 years) at baseline and by 266 and 152, respectively, at follow-up. At baseline, the consulting physician proposed PDE5 inhibitor treatment for 99% of patients, and EHS mean values were similar in patients and partners. All outcomes improved significantly (P