NCT07332949

Brief 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. 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 In addition, the existing scientific literature remains limited, often outdated, and predominantly focused on male patients.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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

December 19, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

December 19, 2025

Last Update Submit

February 3, 2026

Conditions

Keywords

HemodialysisPeritoneal dialysisSexuality

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At baseline, during a dialysis session

Secondary Outcomes (1)

  • Body perception

    At baseline, during a dialysis session

Study Arms (1)

Adults treated with chronic dialysis

Other: Questionnaire on sexuality

Interventions

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.

Adults treated with chronic dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambroise Paré - Hartmann Private Hospital Group

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

RECRUITING

MeSH Terms

Conditions

Sexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 12, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations