Sexual and Urinary Dysfunctions in Generalized Myasthenia (MYAOUS)
Sexual and Urinary Dysfunctions in Generalized Myasthenia: Impact on Quality of Life - the MYAOUS Study
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Saskia BRESCH
- Telefoonnummer: 04 92 03 83 20
- E-mail: Bresch.s@chu-nice.fr
Studie Locaties
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Nice, Frankrijk, 06000
- Nice University Hospital
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Hoofdonderzoeker:
- Saskia Bresch
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Contact:
- Saskia BRESCH
- Telefoonnummer: 04 92 03 83 20
- E-mail: Bresch.s@chu-nice.fr
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Paris, Frankrijk, 75000
- APHP and Myology institute
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Contact:
- BIRNBAUM Simone
- Telefoonnummer: 33 1 42 16 58 79
- E-mail: s.birnbaum@institut-myologie.org
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Hoofdonderzoeker:
- Sophie DEMERET
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Minimum age of 18 years at the time the informed consent form is obtained.
Confirmed diagnosis of generalized autoimmune myasthenia gravis, including at least two of the following:
- Typical clinical features assessed by a physician specializing in myasthenia gravis
- A decrease of ≥ 10% during repeated nerve stimulation (3-5 Hz) or increased irregularity on a single-fiber electromyogram
- A positive edrophonium test or response to anticholinesterase agents
- Serum anti-AChR or anti-MuSK antibodies.
- Enrolled in or covered by a social security program in accordance with current regulations governing research involving human subjects.
Exclusion Criteria:
- Pregnant (at the time of enrollment)
- Postpartum < 6 months
- Severe cognitive impairment or under legal guardianship, making it impossible to understand or complete self-administered questionnaires.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Myasthenic patient with genitourinary and sphincter disorders
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no intervention
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Classification of Sexual Dysfunction in Patients with Generalized Autoimmune Myasthenia
Tijdsspanne: At inclusion
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The sexual complaints questionnaire (QPS questionnaire) assesses sexual complaints over the past six months-on a scale of 0 to 9
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At inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Assessment of Bladder and Sphincter Disorders
Tijdsspanne: at inclusion
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Urinary Symptoms Questionnaire score from 0 to 21
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at inclusion
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Evaluation of Anorectal Disorders
Tijdsspanne: at inclusion
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The Neurogenic Bowel Dysfunction Score is a questionnaire used to assess the main digestive symptoms in people with diseases score 0 to 10
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at inclusion
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The Impact of Myasthenia on Daily Life
Tijdsspanne: at inclusion
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Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire - score 0 to 24
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at inclusion
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Impact of Myasthenia Gravis on Quality of Life
Tijdsspanne: at inclusion
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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
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at inclusion
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Health-Related Quality of Life impact
Tijdsspanne: at inclusion
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Health-Related Quality of Life Questionnaire - measures self-reported health on a scale ranging from 0 to 100
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at inclusion
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the impact of fatigue on daily life
Tijdsspanne: at inclusion
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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
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at inclusion
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Neoplasmata per site
- Neoplasmata
- Neuromusculaire aandoeningen
- Auto-immuunziekten
- Ziekten van het immuunsysteem
- Auto-immuunziekten van het zenuwstelsel
- Neurodegeneratieve ziekten
- Paraneoplastische syndromen, zenuwstelsel
- Neoplasmata van het zenuwstelsel
- Paraneoplastische syndromen
- Neuromusculaire junctieziekten
- Myasthenia Gravis
Andere studie-ID-nummers
- 25-PP-12
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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