CopenHeartSFA 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

Sexual function is an important aspect of quality of life. There is a link between heart disease and sexual dysfunction. Heart disease lowers the activity or the ability to perform the sexual activity. Sexual problems have a negative impact on quality of life and well-being, and sexual dysfunction is associated with anxiety and depression. The causes of sexual dysfunction are physical changes (the disease), mental changes and adverse reactions from medication. Despite the fact, that several international guidelines recommend that health professionals address sexual function in patients with heart disease, this is rarely done in practice. In Denmark there is no consensus or practice on how or where patients with heart disease and sexual dysfunction should be treated. Some patients are treated with phosphodiesterase type 5 inhibitors and a few referred to sexological clinics. Non-pharmacological rehabilitation interventions such as physical exercise, pelvic floor exercise, and sexual therapy have shown potential beneficial effect on sexual function. However, the effects have not been tested sufficiently, have not been tested in combination, and have never been tested in a Danish population. Objective: The objective of this trial is to investigate the effect of a comprehensive sexual rehabilitation intervention program, consisting of a psycho-educative component and an exercise-training component plus treatment as usual versus treatment as usual in male patients with impaired sexual function and implantable cardioverter defibrillator or ischemic heart disease. Design: CopenHeartSF is an investigator-initiated randomised clinical trial with blinded outcome assessment, including two university hospitals, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone.