Erectile DysfunctionNCT03222388
Electronic IIEF Validation
An observational study of Erectile Dysfunction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Questionnaire - IIEF 5/15
- How many people
- 173 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2017to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be included at the outpatient clinic of the urology department at the Academic Medical Center in Amsterdam.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
AMC University Hospital
Amsterdam, North Holland, 1105 AZ
About this study
Official title: Electronic Validation of the International Index of Erectile Function Questionnaire (IIEF) 5 and 15.
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
- Being tested
- Questionnaire - IIEF 5/15
- Keywords
- IIEF, electronic validation
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire - IIEF 5/15Other
International Index of Erectile Function
| Study group | Role | What they receive |
|---|---|---|
| IIEF5 paper-electronic | Not described Receives: Other: Questionnaire - IIEF 5/15 | |
| IIEF5 electronic-paper | Not described Receives: Other: Questionnaire - IIEF 5/15 | |
| IIEF15 paper-electronic | Not described Receives: Other: Questionnaire - IIEF 5/15 | |
| IIEF15 electronic-paper | Not described Receives: Other: Questionnaire - IIEF 5/15 | |
| IIEF5 electronic-electronic | Not described Receives: Other: Questionnaire - IIEF 5/15 | |
| IIEF15 electronic-electronic | Not described Receives: Other: Questionnaire - IIEF 5/15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
The electronic IIEF-5 and 15 questionnaire is reliable when the ICC is ≥0.7, when compared with the paper version.
Measured: Per subject, thus 7 days.
Secondary outcomes (1)
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.
Measured: Per subject, after 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start25 Jul 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Société Internationale d'Urologie
- Responsible party
- Principal investigator, Prof.dr. J.J.M.C.H. de la Rosette, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222388
- Sponsor's protocol ID
- 17.281
- Status last verified
- Jun 2018
- First submitted
- 27 Jun 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31267983
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Validation of the International Index of Erectile Function Questionnaire (IIEF) 5 and 15.
- ClinicalTrials.gov ID
- NCT03222388
- Acronym / sponsor ID
- 17.281
- Conditions
- Erectile Dysfunction
- Keywords
- IIEF, electronic validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Société Internationale d'Urologie
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be included at the outpatient clinic of the urology department at the Academic Medical Center in Amsterdam.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire - IIEF 5/15International Index of Erectile Function | Other | IIEF15 electronic-electronic, IIEF15 electronic-paper, IIEF15 paper-electronic, IIEF5 electronic-electronic, IIEF5 electronic-paper, IIEF5 paper-electronic |
Primary outcome
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.
1 secondary outcome
Preference for paper or electronic
Time frame: Per subject, after 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Derived from this study: PubMed 31267983van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: Per subject, thus 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.