Sexual Dysfunction in Cirrhosis

Condition(s) studied

Investigational drug(s) / intervention(s)

questionnaire: Completion of questionnaires (IIEF5/FSFI, SF 36, Fatigue Scale Score, Self Esteem Inventory, Hospital Anxiety and Depression Scale) during the pre-transplant consultation, then during a consultation 6 months after transplantation

blood collection: Collection of 2 tubes of 5mL of blood during a scheduled blood draw in the patient's care pathway. This sample will also be taken after the transplant (6 months later)

Study summary

The prevalence of erectile dysfunction (ED) is about 10% in the general population, but increases with age, ranging from 9.1% in men 40-49 years to 55% in men \>70. The major risk factors for ED are as follows: diabetes; heart conditions; tobacco use; obesity; injuries to the nerves that control erection; medications such as antidepressants; psychological conditions such as stress, anxiety, or depression; and drug or alcohol use (4). The International Index of Erectile Function (IIEF5) is a simple and well-validated tool for the evaluation of ED (5) and is considered the gold standard for the diagnosis and evaluation of symptom severity. The link between cirrhosis and ED has been suggested in a recent study, showing ED was also impacted by liver failure, portal hypertension and other known risk factors. In the investigators team, they showed, additionally, that neurocognitive impairment is associated with ED in cirrhosis (data not published). The prevalence of ED after liver transplantation (LT) varies among series, ranging from 66 to 86%.

After LT, on the one hand, improvement of liver function and bioavailable testosterone favours the improvement of ED. On the other hand, immunosuppressive agents are suspected to worsen it.

ED's reversibility has also been discussed; nevertheless, data are scarce and heterogeneous.

In the investigators group, they can perform in routine a neurocognitive evaluation of patients with cirrhosis thanks to a neuropsychologist experienced in cognitive disorders occurring in patients with cirrhosis. The aims of this study are: 1) to compare the prevalence of erectile dysfunction (ED) in a population of patients with cirrhosis before liver transplantation (LT) and one year after LT; (2) to describe factors associated with ED before and after LT, with a special focus of hormonal profile, neurocognitive impairment, multimodal brain Magnetic resonance imaging (MRI) and of the type of immunosuppressive therapy used; (3) to assess the impact of ED on sexual partner; (4) to evaluate the efficacy of the treatment with phosphodiesterase-5 inhibitors (PDE-5) drugs after LT.

Methods: neurocognitive tests will be performed by an expert neuropsychologist. Biological evaluation will include an evaluation of liver function, hormonal assessment (bioavailable testosterone). MRI acquisition protocol will include anatomical sequences (3D-T1, FLAIR, T2, T2

\*), diffusion tensor imaging (DTI) and two single voxel MR spectroscopy acquisitions. Evaluation will be performed before LT and 1 year after LT.

Eligibility

Primary outcome measure(s)

• Impact of liver transplantation on sexual dysfunction in patients with cirrhosis — through study completion, an average of 30 months
  The impact of liver transplantation on sexual dysfunction will be assessed by a comparison of questionnaires global results before and after the transplantation. For men investigators will use International Index of Erectile Function (IIEF5) questionnaire, and for women the Female Sexual Function Index (FSFI) questionnaire.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France