Chronic Kidney Disease Requiring Chronic DialysisSEXODIANCT07332949
Impact of Dialysis on Sexuality.
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis, run by CMC Ambroise Paré at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Questionnaire on sexuality
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2026to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults treated with chronic dialysis (hemodialysis or peritoneal dialysis).
Who may be able to join
- Patient > 18 years,
- Treated with chronic dialysis (hemodialysis or peritoneal dialysis) for at least 6 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Ambroise Paré - Hartmann Private Hospital Group
Neuilly-sur-Seine, Île-de-France Region, 92200
Nicolas Benichou, MD, 0146415079 ext. +33, nicolas.benichou@clinique-a-pare.fr
About this study
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.
Read more
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.
- Being tested
- Questionnaire on sexuality
- Keywords
- Hemodialysis, Peritoneal dialysis, Sexuality
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on sexualityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults treated with chronic dialysis | Not described Receives: Other: Questionnaire on sexuality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual quality of life
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.
Measured: At baseline, during a dialysis session
Sexual quality of life
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.
Measured: At baseline, during a dialysis session
Secondary outcomes (1)
Body perception
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.
Measured: At baseline, during a dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 Jan 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332949
- Sponsor's protocol ID
- 2025/04
- Other IDs
- 2025-A02271-48
- Acronym
- SEXODIA
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dialysis on Sexuality.
- ClinicalTrials.gov ID
- NCT07332949
- Acronym / sponsor ID
- SEXODIA / 2025/04
- Keywords
- Hemodialysis, Peritoneal dialysis, Sexuality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults treated with chronic dialysis | – | Other: Questionnaire on sexuality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults treated with chronic dialysis (hemodialysis or peritoneal dialysis).
Key inclusion criteria (2 listed)
- Patient > 18 years,
- Treated with chronic dialysis (hemodialysis or peritoneal dialysis) for at least 6 months.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire on sexualityThe 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. | Other | Adults treated with chronic dialysis |
Primary outcome
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.
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.
1 secondary outcome
Body perception
Time frame: At baseline, during a dialysis session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Benichou, MD (0146415079 ext. +33, nicolas.benichou@clinique-a-pare.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual quality of life (time frame: At baseline, during a dialysis session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.