Electronic IIEF Validation

Study Overview
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Brief Summary
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Questionnaires are used within urology to objectify disease burden and symptom changes during therapy. Recent technological improvements, as the smartphone and tablet, create new fill-out possibilities. However, questionnaires are only validated on paper. In order to use questionnaires for multiple platforms, electronic validation is needed. The International Prostate Symptom Score has already been validated on the smartphone. The International Index of Erectile Function (normal version of 15 questions and short version of 5 questions) is widely used within urology, however electronic validation is required for usage on electronic platforms in the future.

Official Title
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Electronic Validation of the International Index of Erectile Function Questionnaire (IIEF) 5 and 15.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Other: Questionnaire - IIEF 5/15


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male patients, ≥40 years of age, presenting at the outpatient clinic of Urology of the Academic Medical Center in Amsterdam. In possession of a smartphone, tablet or laptop/computer with internet connection. Access to email. Fluent speaking and reading the Dutch language. Exclusion criteria: Change in treatment, especially erectile dysfunction at consultation which could impact the short term IIEF outcome during the cross-over time. Unable to provide informed consent. Unfit according to the medical doctor (for example cognitive problems, leading to inadequate follow-up of instructions).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IIEF5 paper-electronic<br> | Other: Questionnaire - IIEF 5/15<br>* International Index of Erectile Function<br>|
| IIEF5 electronic-paper<br> | Other: Questionnaire - IIEF 5/15<br>* International Index of Erectile Function<br>|
| IIEF15 paper-electronic<br> | Other: Questionnaire - IIEF 5/15<br>* International Index of Erectile Function<br>|
| IIEF15 electronic-paper<br> | Other: Questionnaire - IIEF 5/15<br>* International Index of Erectile Function<br>|
| IIEF5 electronic-electronic<br> | Other: Questionnaire - IIEF 5/15<br>* International Index of Erectile Function<br>|
| IIEF15 electronic-electronic<br> | Other: Questionnaire - IIEF 5/15<br>* International Index of Erectile Function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability | The electronic IIEF-5 and 15 questionnaire is reliable when the ICC is ≥0.7, when compared with the paper version. | Per subject, thus 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference for paper or electronic | The electronic version of the IIEF-5 and 15 is preferred when ≥70% of the subjects have no preference or prefer the electronic version over the paper version. | Per subject, after 7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IIEF, electronic validation