Sexual Dysfunction Clinical Trial
— CopenHeartSFOfficial title:
A Randomized Clinical Trial of a Comprehensive Sexual Rehabilitation Programme Versus Usual Care in Male Patients With Impaired Sexual Function and Ischemic Heart Disease or Implantable Cardioverter Defibrillator
Verified date | May 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective is to investigate the effect of a comprehensive sexual rehabilitation program,
consisting of a psycho-educative component and a physical exercise component.
The primary hypothesis is that, a comprehensive sexual rehabilitation program improves
sexual function.
Status | Completed |
Enrollment | 154 |
Est. completion date | January 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male patients above 18 years with sexual dysfunction associated with implantable cardioverter defibrillator or with ischemic heart disease verified by coronary angiography, which have a partner, speaks and understands Danish and provides a written informed consent Exclusion Criteria: - Patients at intermediate or high risk according to their cardiovascular status according to guidelines, with diseases in the urinary tract, who exercise intense more than 3 hours a week, patients with neurological or orthopedic deficits which prevent training, patients with cognitive deficits which prevents interviews, and patients who are included in ongoing research prohibiting additional research participation are excluded. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9 | Copenhagen | OE |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Bispebjerg Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Index of Erectile Function (IIEF) | 16 week | ||
Secondary | Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain | 16 week |
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