Sexual Dysfunction in Patients With Chronic Liver Disease

This project will determine the incidence of sexual dysfunction in patients with chronic liver disease, through questionnaires. The questionnaires have been designed to assess several facets of sexual health, e.g. libido, physical symptoms, depression, etc. 150 patients in our liver outpatient department, and 150 healthy volunteers will be asked to fill in the questionnaire in paper form. The results of this project will be used to produce patient resources, advice sheets and educational materials for patients with chronic liver disease. There is also scope to consider possible interventions in the future to improve sexual dysfunction in patients with chronic liver disease.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Diseases; Liver Cirrhosis
• Intervention / Treatment: Diagnostic test: Sexual function questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Refah Z Ahmed, BA MSc; Phone Number: 02032997150; Email: refah.ahmed1@nhs.net
• Study Contact Backup: Name: Mussarat Rahim, MBBS BSc MRCP; Phone Number: 02032994241; Email: mussaratrahim@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Institute of Liver Studies
    • Contact: Refah Z Ahmed, BA MSc; Phone Number: 02032997150; Email: refah.ahmed1@nhs.net
    • Contact: Mussarat Rahim, MBBS BSc MRCP; Phone Number: 02032994241; Email: mussaratrahim@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic liver disease

Description

Inclusion Criteria:

• Diagnosis of a chronic liver disease (including those who have had liver transplantation)
• Aged 18-75
• Able to give informed written consent

Exclusion Criteria:

• Major psychiatric disease
• Patients who lack capacity
• Patient with no chronic liver disease
• Patients not proficient in English

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Diagnostic test: Sexual function questionnaire; Sexual function questionnaire and cognitive screening assessments
Chronic liver disease	Diagnostic test: Sexual function questionnaire; Sexual function questionnaire and cognitive screening assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with sexual dysfunction	The number of patients suffering from sexual dysfunction in patients with chronic liver disease	12 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 272717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No