Sexual Dysfunction Clinical Trial
Official 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
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.
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.
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