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Electronic IIEF Validation

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ClinicalTrials.gov Identifier: NCT03222388
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Société Internationale d'Urologie
Information provided by (Responsible Party):
Prof.dr. J.J.M.C.H. de la Rosette, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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
Erectile Dysfunction Other: Questionnaire - IIEF 5/15

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 : July 25, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Group/Cohort 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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222388


Locations
Netherlands
AMC University Hospital
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Société Internationale d'Urologie

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     History of Changes
Other Study ID Numbers: 17.281
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
IIEF
electronic validation

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders