Evaluating erectile dysfunction in patients with cirrhosis before and after liver transplantation
Sexual Dysfunction in Patients With Cirrhosis Before and After Liver Transplantation
This study is testing how common erectile dysfunction is in people with cirrhosis before and after they have a liver transplant, and whether certain treatments can help improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05428267 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of erectile dysfunction (ED) in patients with cirrhosis both prior to and one year following liver transplantation. It will explore factors associated with ED, including hormonal profiles and neurocognitive impairment, while also evaluating the effectiveness of phosphodiesterase-5 inhibitors as a treatment option. The study will utilize the International Index of Erectile Function (IIEF5) for diagnosis and severity assessment. Blood samples will be collected, and questionnaires will be administered to gather comprehensive data on participants' conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are men with cirrhosis who are awaiting liver transplantation and do not have urgent indications for surgery.
Not a fit: Patients with clinical hepatic encephalopathy, dementia, or a history of prostatic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of erectile dysfunction in patients with cirrhosis, enhancing their quality of life post-transplant.
How similar studies have performed: While studies have explored erectile dysfunction in various populations, this specific focus on cirrhosis and liver transplantation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) cirrhosis; (2) non-urgent indication for LT. Exclusion Criteria: * (1) clinical HE; (2) dementia; (3) language barrier; (4) past history of prostatic surgery
Where this trial is running
Paris
- Service d'hépato-gastroentérologie Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Marika Rudler, MD, PhD
- Email: marika.rudler@aphp.fr
- Phone: +33142161454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.