Electronic IIEF Validation

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222388
• Other study ID #: 17.281
• Status: Completed
• Start date: July 25, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: June 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• Questionnaire - IIEF 5/15
International Index of Erectile Function

Locations

Country	Name	City	State
Netherlands	AMC University Hospital	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Société Internationale d'Urologie

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.