Sexual Dysfunction in Cirrhosis
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 230 people, planned
- Started
- 26 May 2023
- Expected to end
- 26 Jul 2028
- Type of study
- Interventional
- Treatments tested
- questionnaire
- blood collection
- Record updated
- 19 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- (1) cirrhosis; (2) non-urgent indication for LT
Who cannot take part
- (1) clinical HE; (2) dementia; (3) language barrier; (4) past history of prostatic surgery
Where in France
- Service d'hépato-gastroentérologie Hôpital Pitié-SalpêtrièreParis, FranceContact: Marika RUDLERTaking people
About the trial
What the trial wants to find out
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%.
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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.
The group in the trial
- Patients on the liver transplant list for cirrhosis.Treatment being tested
Prevalence of sexual dysfunction before and after LT
Treatment: questionnaire and blood collection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sexual Dysfunction in Patients With Cirrhosis Before and After Liver Transplantation
- Record updated
- 19 October 2026