- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332949
Impact of Dialysis on Sexuality. (SEXODIA)
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 In addition, the existing scientific literature remains limited, often outdated, and predominantly focused on male patients.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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nicolas Benichou, MD
- Phone Number: +33 0146415079
- Email: nicolas.benichou@clinique-a-pare.fr
Study Locations
-
-
Île-de-France Region
-
Neuilly-sur-Seine, Île-de-France Region, France, 92200
- Recruiting
- Ambroise Paré - Hartmann Private Hospital Group
-
Contact:
- Nicolas Benichou, MD
- Phone Number: +33 0146415079
- Email: nicolas.benichou@clinique-a-pare.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults treated with chronic dialysis
|
The patients will receive the following questionnaires to complete during the dialysis session:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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