Assessing Satisfaction After PDE5 Inhibitor Treatment for ED
Assessing Satisfaction After PDE5 Inhibitor Treatment for ED
This study was conducted from June 2007 to March 2009 at two medical centers in Taiwan. Patients were eligible for the study if they were >20 years of age, had taken PDE5 inhibitors for at least 3 months for ED and had a stable relationship with a female partner.
Participants were given an envelope that contained two self-administered questionnaires: one for the patient and the other for his female partner, which were to be answered separately at home. The completed questionnaires were returned by mail. The protocol of this study was reviewed and approved by the Institutional Review Board at Kaohsiung Veterans General Hospital.
The questionnaire for completion by male patients with ED contained 36 items that included demographic data, marital status, a checklist of self-reported comorbidity, characteristics of administering PDE5 inhibitors, a checklist of side effects, the Sexual Health Inventory for Men (SHIM) before and after treatment, and a nonvalidated Chinese version of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). With the exception of SHIM and EDITS, which are validated questionnaires, the other questions have not been validated. Baseline erectile function was determined by recalling the erectile status before treatment. Given the cross-sectional study design, this process involved the modified version of SHIM. The questionnaire for completion by female partners of men with ED contained only a 5-item Chinese version of the EDITS Partner.
The EDITS questionnaire contained 11 questions that were scored on a 0–4-point scale, with a higher score indicating greater satisfaction. An EDITS Index was calculated by multiplying the mean score of all 11 questions by 25, resulting in a range from 0 (lowest satisfaction) to 100 (highest satisfaction). The EDITS Partner questionnaire contained five items scored on a 0–4-point scale, and its Index was calculated in the same way as that used for the EDITS questionnaire. Treatment satisfaction was defined as an EDITS Index or EDITS Partner Index score ≥50, and treatment dissatisfaction as an Index score <50. The severity of ED was based on the total SHIM score, with 22–25 representing no ED, 17–21 representing mild ED, 12–16 representing mild to moderate ED, 8–11 representing moderate ED and <7 representing severe ED.
Descriptive statistics were used for demographic variables. The χtest was used for the analysis of categorical data. A paired-samples t-test was conducted to compare the dependent variables. Student's t-test and the Mann–Whitney U-test were used for parametric and nonparametric variables, respectively. Spearman's rank correlation was used to measure the association between the EDITS and the EDITS Partner Index scores. Data entry was performed using Excel 2000 (Microsoft, Redmond, WA, USA). Statistical analyses were executed using SPSS version 12.0 (Chicago, IL, USA). The null hypothesis was rejected for P<0.05.
Patients and Methods
Patients
This study was conducted from June 2007 to March 2009 at two medical centers in Taiwan. Patients were eligible for the study if they were >20 years of age, had taken PDE5 inhibitors for at least 3 months for ED and had a stable relationship with a female partner.
Questionnaires
Participants were given an envelope that contained two self-administered questionnaires: one for the patient and the other for his female partner, which were to be answered separately at home. The completed questionnaires were returned by mail. The protocol of this study was reviewed and approved by the Institutional Review Board at Kaohsiung Veterans General Hospital.
The questionnaire for completion by male patients with ED contained 36 items that included demographic data, marital status, a checklist of self-reported comorbidity, characteristics of administering PDE5 inhibitors, a checklist of side effects, the Sexual Health Inventory for Men (SHIM) before and after treatment, and a nonvalidated Chinese version of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). With the exception of SHIM and EDITS, which are validated questionnaires, the other questions have not been validated. Baseline erectile function was determined by recalling the erectile status before treatment. Given the cross-sectional study design, this process involved the modified version of SHIM. The questionnaire for completion by female partners of men with ED contained only a 5-item Chinese version of the EDITS Partner.
The EDITS questionnaire contained 11 questions that were scored on a 0–4-point scale, with a higher score indicating greater satisfaction. An EDITS Index was calculated by multiplying the mean score of all 11 questions by 25, resulting in a range from 0 (lowest satisfaction) to 100 (highest satisfaction). The EDITS Partner questionnaire contained five items scored on a 0–4-point scale, and its Index was calculated in the same way as that used for the EDITS questionnaire. Treatment satisfaction was defined as an EDITS Index or EDITS Partner Index score ≥50, and treatment dissatisfaction as an Index score <50. The severity of ED was based on the total SHIM score, with 22–25 representing no ED, 17–21 representing mild ED, 12–16 representing mild to moderate ED, 8–11 representing moderate ED and <7 representing severe ED.
Statistical Analysis
Descriptive statistics were used for demographic variables. The χtest was used for the analysis of categorical data. A paired-samples t-test was conducted to compare the dependent variables. Student's t-test and the Mann–Whitney U-test were used for parametric and nonparametric variables, respectively. Spearman's rank correlation was used to measure the association between the EDITS and the EDITS Partner Index scores. Data entry was performed using Excel 2000 (Microsoft, Redmond, WA, USA). Statistical analyses were executed using SPSS version 12.0 (Chicago, IL, USA). The null hypothesis was rejected for P<0.05.