Electronic IIEF Validation

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Completed
• CT.gov ID: NCT03222388
• Collaborator: Société Internationale d'Urologie (Other)
• Enrollment: 173
• Location: 1
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 32.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Other: Questionnaire - IIEF 5/15

Study Design

• Study Type: Observational
• Actual Enrollment: 173 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Electronic Validation of the International Index of Erectile Function Questionnaire (IIEF) 5 and 15.
• Actual Study Start Date: Jul 25, 2017
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
IIEF5 paper-electronic	Other: Questionnaire - IIEF 5/15; International Index of Erectile Function
IIEF5 electronic-paper	Other: Questionnaire - IIEF 5/15; International Index of Erectile Function
IIEF15 paper-electronic	Other: Questionnaire - IIEF 5/15; International Index of Erectile Function
IIEF15 electronic-paper	Other: Questionnaire - IIEF 5/15; International Index of Erectile Function
IIEF5 electronic-electronic	Other: Questionnaire - IIEF 5/15; International Index of Erectile Function
IIEF15 electronic-electronic	Other: Questionnaire - IIEF 5/15; International Index of Erectile Function

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMC University Hospital	Amsterdam	Noord-Holland	Netherlands	1105 AZ

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof.dr. J.J.M.C.H. de la Rosette, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT03222388
• Other Study ID Numbers: 17.281
• First Posted: Jul 19, 2017
• Last Update Posted: Jun 8, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof.dr. J.J.M.C.H. de la Rosette, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): IIEF; electronic validation
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Jun 8, 2018