Electronic IIEF Validation

NCT03222388 | Completed

• 1 other identifier: 17.281
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

IIEF; electronic validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Preference for paper or electronic

  Per subject, after 7 days.

Study Arms (6)

IIEF5 paper-electronic

Other: Questionnaire - IIEF 5/15

IIEF5 electronic-paper

Other: Questionnaire - IIEF 5/15

IIEF15 paper-electronic

Other: Questionnaire - IIEF 5/15

IIEF15 electronic-paper

Other: Questionnaire - IIEF 5/15

IIEF5 electronic-electronic

Other: Questionnaire - IIEF 5/15

IIEF15 electronic-electronic

Other: Questionnaire - IIEF 5/15

Interventions

Questionnaire - IIEF 5/15 OTHER

International Index of Erectile Function

IIEF15 electronic-electronic; IIEF15 electronic-paper; IIEF15 paper-electronic; IIEF5 electronic-electronic; IIEF5 electronic-paper; IIEF5 paper-electronic

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be included at the outpatient clinic of the urology department at the Academic Medical Center in Amsterdam.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Société Internationale d'Urologie: collaborator

Study Sites (1)

AMC University Hospital

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

• van Kollenburg RAA, de Bruin DM, Wijkstra H. Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study. J Med Internet Res. 2019 Jul 2;21(7):e13490. doi: 10.2196/13490.

  PMID: 31267983 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 19, 2017
• Study Start: July 25, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

NL (1)