Sexual Dysfunction in Cirrhosis

NCT05428267 | Recruiting

• 1 other identifier: APHP220052
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexual Dysfunction in Patients With Cirrhosis Awaiting Liver Transplantation

Keywords

Cirrhosis; Sexual dysfunction

Outcome Measures

Primary Outcomes (1)

• Impact of liver transplantation on sexual dysfunction in patients with cirrhosis

  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.

  through study completion, an average of 30 months

Secondary Outcomes (4)

• Prevalence of sexual dysfunction in patients with cirrhosis. Safety issues No

  through study completion, an average of 30 months

• Factors associated with sexual dysfunction in patients with cirrhosis

  through study completion, an average of 30 months

• Hormonal concentration associated with sexual dysfunction in patients with cirrhosis

  through study completion, an average of 30 months

• Prevalence of sexual dysfunction in patients who underwent liver transplantation

  through study completion, an average of 30 months

Study Arms (1)

Patients on the liver transplant list for cirrhosis.

EXPERIMENTAL

Prevalence of sexual dysfunction before and after LT

Other: questionnaire; Other: blood collection

Interventions

questionnaire OTHER

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

Patients on the liver transplant list for cirrhosis.

blood collection OTHER

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)

Patients on the liver transplant list for cirrhosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) cirrhosis; (2) non-urgent indication for LT.

You may not qualify if:

• (1) clinical HE; (2) dementia; (3) language barrier; (4) past history of prostatic surgery

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'hépato-gastroentérologie Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Fibrosis; Sexual Dysfunction, Physiological

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Central Study Contacts

Marika Rudler, MD, PhD

CONTACT

+33142161454; marika.rudler@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 23, 2022
• Study Start: May 26, 2023
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): July 26, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-11

Locations

FR (1)