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<0.05), including EHS in 75% of men (EHS3 [hardness sufficient for sexual intercourse but not fully hard] improved to EHS4 [fully hard erection] in almost 60%). For most other outcomes, improvement was greater in younger men and in those who improved from EHS3 to EHS4.

Conclusions: Strong agreement in EHS between patient and partner and associations between improvement in EHS and improvements in measures of sexual function and quality of life in patients and partners support its clinical use in ED management.