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OpenTrials
Completed

NCT Number: NCT03222388

Electronic IIEF Validation

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

AMC University Hospital

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Questionnaire - IIEF 5/15

Other

International Index of Erectile Function

Primary outcomes

  1. Reliability

    Time frame: 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 outcomes

  1. Preference for paper or electronic

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Société Internationale d'Urologie

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2017
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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