No intervetion
Otherno intervention
NCT Number: NCT07677852
Myasthenia gravis is an autoimmune disease caused by specific autoantibodies that disrupt the function of the neuromuscular junction. It manifests as excessive fatigue of the skeletal muscles during physical exertion and affects 15,000 people in France. Initial symptoms are most often ocular (ptosis, diplopia) but can later spread throughout the body, potentially leading in some cases to respiratory failure and/or swallowing difficulties (myasthenic crisis) or even death. This condition is currently being managed more effectively through treatment, and the invisible symptoms (sexual dysfunction, sphincter dysfunction, psychological impact, etc.) may ultimately be more debilitating than the initial symptoms, which are often controlled by maintenance and/or symptomatic treatments. The impact of myasthenia gravis on intimate life remains a taboo subject and is poorly understood by both the medical community and patients. In the literature, only a single article from 2021 addresses sexual dysfunction in patients with myasthenia gravis. Urinary disorders in myasthenia gravis are frequently reported but have also been little studied.
A national survey, conducted using an online questionnaire distributed by patient associations, shed light on the disease's impact on patients' intimate lives. In this study of 190 patients, 46 of them responded to the question about sexual function, and one in two patients reported sexual complaints; in 46% of cases, this disorder significantly impacted the patients' daily lives. In particular, a decrease in the frequency of sexual intercourse with a partner was noted in 55% of cases, as well as a decrease in sexual desire in 51% of cases.
Sexual dysfunction is very common and underreported in many chronic neurological diseases. The Sexual Complaints Screener (SCS W/M) questionnaires for women and men in English have very recently been validated in French (Questionnaires de Plaintes Sexuelles, QPS F/H).
It now have a 10-item self-administered questionnaire that assesses the full range of sexual disorders and their impact.
In conclusion, while the visible symptoms of myasthenia gravis are widely recognized, the invisible symptoms-such as genitourinary and sphincter disorders-remain largely unrecognized and underdiagnosed. It is therefore essential to conduct systematic screening in order to best guide our patients and thereby improve their quality of life.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Nice University hospital, Nice, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
no intervention
Time frame: At inclusion
The sexual complaints questionnaire (QPS questionnaire) assesses sexual complaints over the past six months-on a scale of 0 to 9
Time frame: at inclusion
Urinary Symptoms Questionnaire score from 0 to 21
Time frame: at inclusion
The Neurogenic Bowel Dysfunction Score is a questionnaire used to assess the main digestive symptoms in people with diseases score 0 to 10
Time frame: at inclusion
Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire - score 0 to 24
Time frame: at inclusion
The Myasthenia Gravis Quality of Life - 15 items (MGQOL-15) is a myasthenia-specific tool consisting of 15 patient-reported items that assesses the physical, psychological, and social domains commonly affected by myasthenia over the past few weeks
Time frame: at inclusion
Health-Related Quality of Life Questionnaire - measures self-reported health on a scale ranging from 0 to 100
Time frame: at inclusion
The quality of life item banks for adults with neurological disorders questionnaire : NeuroQoL Fatigue Short Form is a brief, validated questionnaire that measures the impact of fatigue on the daily lives of patients with neurological disorders and consists of 8 questions
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
Sexual and Urinary Dysfunctions in Generalized Myasthenia: Impact on Quality of Life - the MYAOUS Study
Acronym: MYAOUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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