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Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial

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ClinicalTrials.gov Identifier: NCT02742896
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

Brief Summary:
Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion

Condition or disease Intervention/treatment
Erectile Dysfunction Other: Erectile dysfunction

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.

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Study Type : Observational
Estimated Enrollment : 358 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial
Study Start Date : December 2013
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: 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.

The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm.

Other Name: official questionnaire




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The changes of cognitive function [ Time Frame: cognitive dysfunction 1 year after conversion to sinus rhythm ]
    The changes of cognitive function by using validated assessment form-The Montreal Cognitive Assessement(MoCA) 1 year after conversion to sinus rhythm



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are scheduled to rhythm control of persistent atrial fibrillation.
Criteria

Inclusion Criteria:

  • Patients scheduled to electrical cardioversion

Exclusion Criteria:

  • 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

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): NCT02742896


Contacts
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Contact: Sung Hwan Kim, professor 82-2-2258-1141 sunghwan@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St Mary's Hospital Recruiting
Seoul, Seo Ch-gu, Korea, Republic of, 137-701
Contact: Sung Hwan Kim, MD    82-10-9109-8957    sunghwan@catholic.ac.kr   
Principal Investigator: Yong Seog Oh, Ph.D         
Sponsors and Collaborators
Yong Seog Oh
Investigators
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Principal Investigator: Yong Seog Oh, MD Seoul St Mary hospital

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Responsible Party: Yong Seog Oh, professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02742896     History of Changes
Other Study ID Numbers: ERECT
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
Erectile dysfunction
cognitive function
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders