Electronic IIEF Validation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03222388

Enrollment

173

Registered

2017-07-19

Start date

2017-07-25

Completion date

2018-01-01

Last updated

2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

IIEF, electronic validation

Brief summary

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.

Interventions

OTHERQuestionnaire - IIEF 5/15

International Index of Erectile Function

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Preference for paper or electronic	Per subject, after 7 days.	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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026