Impact of Dialysis on Sexuality. (SEXODIA)

February 3, 2026 updated by: CMC Ambroise Paré

Sexuality is an essential dimension of quality of life and is frequently impaired in patients with end-stage chronic kidney disease undergoing hemodialysis. Sexual dysfunctions-including erectile dysfunction, reduced sexual desire, and difficulties with arousal or orgasm-are highly prevalent in this population. These disorders have multifactorial origins, involving hormonal disturbances, comorbidities, treatment-related side effects, chronic fatigue, and the psychological and relational impact of long-term illness.

Despite their frequency, sexual health issues are rarely addressed in routine dialysis care. This is largely due to time constraints during consultations, insufficient training of healthcare professionals, and persistent social and cultural taboos. In addition, the existing scientific literature remains limited, often outdated, and predominantly focused on male patients. Data concerning women, sexual diversity, body image, and couple-related aspects are scarce. Standard kidney disease-specific quality-of-life instruments, such as the KDQOL questionnaire, provide only a minimal assessment of sexuality, with a single item related to sexual desire.

The aim of this study is to provide a contemporary and comprehensive assessment of the impact of dialysis on sexual quality of life. By documenting sexual function and sexual complaints in patients undergoing dialysis, this study seeks to improve understanding of patients' experiences and to facilitate communication between patients and healthcare professionals. Ultimately, the findings are intended to support better integration of sexual health into routine nephrology care and to contribute to improved clinical practices in the field of sexual health.

This study is designed as a cross-sectional survey conducted among patients undergoing dialysis at the Groupe Hospitalier Privé Ambroise Paré-Hartmann in the Paris area. Eligible patients are informed about the study during a dialysis session by a healthcare professional (dialysis nurse, nephrologist, or physiotherapist specialized in sexology). Participants complete a self-administered questionnaire during their dialysis session, including the Male Sexual Health Questionnaire (MSHQ) for men and the Female Sexual Function Index (FSFI) for women. Additional questions addressing medical history and body image perception are included. The estimated completion time for the questionnaire is approximately 20 minutes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Île-de-France Region
      • Neuilly-sur-Seine, Île-de-France Region, France, 92200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults treated with chronic dialysis (hemodialysis or peritoneal dialysis).

Description

Inclusion Criteria:

  • Patient > 18 years,
  • Treated with chronic dialysis (hemodialysis or peritoneal dialysis) for at least 6 months.

Exclusion Criteria:

  • Major cognitive or psychiatric disorders that make understanding or completing the questionnaire difficult.
  • General health condition not allowing participation without significant discomfort or excessive fatigue.
  • Opposition by the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adults treated with chronic dialysis
Other: Questionnaire on sexuality

The patients will receive the following questionnaires to complete during the dialysis session:

  • MSHQ (Male Sexual Health Questionnaire) for men
  • FSFI (Female Sexual Function Index) for women Additional questions addressing medical history and body image perception are included.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual quality of life
Time Frame: At baseline, during a dialysis session
The MSHQ questionnaire for men consists of 25 questions, minimum score: 25, maximum score: 125. A higher score on this scale indicates better sexual function.
At baseline, during a dialysis session
Sexual quality of life
Time Frame: At baseline, during a dialysis session
The FSFI questionnaire for women consists of 19 questions, minimum score: 2, maximum score: 36. A higher score on this scale indicates better sexual function.
At baseline, during a dialysis session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body perception
Time Frame: At baseline, during a dialysis session
Questionnaire adapted from the Body Image Scale consisting of 4 questions, minimum score: 0, maximum score: 12. A higher score indicates a poorer body image.
At baseline, during a dialysis session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CMC Ambroise Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/04
  • 2025-A02271-48 (Registry Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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