Erectile DysfunctionNCT02742896
Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial
An observational study of Erectile Dysfunction, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Erectile dysfunction
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to 1 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are scheduled to rhythm control of persistent atrial fibrillation.
Who may be able to join
- Patients scheduled to electrical cardioversion
Who cannot join
- Patients have taken any medication for erectile dysfunction or who have got any operation already or are scheduled to do.
- More than moderate degree of cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion
Read the detailed description
Sinus conversion by electrical cardioversion increase cardiac output and systemic perfusion. According to recent reports, maintenance of sinus rhythm increase systemic perfusion which leads to improve renal function. Therefore, we hypothesized that sinus conversion of patients with atrial fibrillation will increase systemic perfusion which might improve the erectile dysfunction and cognitive dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Erectile dysfunction
- Keywords
- Erectile dysfunction, cognitive function
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erectile dysfunctionOther
Also called official questionnaire
The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.
The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm.
| Study group | Role | What they receive |
|---|---|---|
| Restoration of Erectile dysfunction | The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm. Receives: Other: Erectile dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of erectile function
The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.
Measured: Erectile dysfunction 1 year after conversion to sinus rhythm.
Secondary outcomes (1)
The changes of cognitive function
The changes of cognitive function by using validated assessment form-The Montreal Cognitive Assessement(MoCA) 1 year after conversion to sinus rhythm
Measured: cognitive dysfunction 1 year after conversion to sinus rhythm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startDec 2013
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- Yong Seog Oh, MD, Principal investigator, Seoul St Mary hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742896
- Sponsor's protocol ID
- ERECT
- Status last verified
- Apr 2024
- First submitted
- 5 Oct 2014
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial
- ClinicalTrials.gov ID
- NCT02742896
- Acronym / sponsor ID
- ERECT
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, cognitive function
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- 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.
Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion
Detailed description
Sinus conversion by electrical cardioversion increase cardiac output and systemic perfusion. According to recent reports, maintenance of sinus rhythm increase systemic perfusion which leads to improve renal function. Therefore, we hypothesized that sinus conversion of patients with atrial fibrillation will increase systemic perfusion which might improve the erectile dysfunction and cognitive dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restoration of Erectile dysfunction | – | Other: Erectile dysfunctionThe changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are scheduled to rhythm control of persistent atrial fibrillation.
Key inclusion criteria (1 listed)
- Patients scheduled to electrical cardioversion
Key exclusion criteria (2 listed)
- Patients have taken any medication for erectile dysfunction or who have got any operation already or are scheduled to do.
- More than moderate degree of cognitive dysfunction
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 |
|---|---|---|
| Erectile dysfunctionAlso: official questionnaireThe changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm. The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm. | Other | Restoration of Erectile dysfunction |
Primary outcome
The changes of erectile function
Time frame: Erectile dysfunction 1 year after conversion to sinus rhythm.
The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.
1 secondary outcome
The changes of cognitive function
Time frame: cognitive dysfunction 1 year after conversion to sinus rhythm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- 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.
Yong Seog Oh, MD principal investigator
Seoul St Mary hospital
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 Yong Seog Oh at 1 site in South Korea.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Apr 2024. 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
The changes of erectile function (time frame: Erectile dysfunction 1 year after conversion to sinus rhythm.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2024.