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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Saskia BRESCH
- 電話番号:04 92 03 83 20
- メール:Bresch.s@chu-nice.fr
研究場所
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Nice、フランス、06000
- Nice University Hospital
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主任研究者:
- Saskia Bresch
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コンタクト:
- Saskia BRESCH
- 電話番号:04 92 03 83 20
- メール:Bresch.s@chu-nice.fr
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Paris、フランス、75000
- APHP and Myology institute
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コンタクト:
- BIRNBAUM Simone
- 電話番号:33 1 42 16 58 79
- メール:s.birnbaum@institut-myologie.org
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主任研究者:
- Sophie DEMERET
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Myasthenic patient with genitourinary and sphincter disorders
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no intervention
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Classification of Sexual Dysfunction in Patients with Generalized Autoimmune Myasthenia
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assessment of Bladder and Sphincter Disorders
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-PP-12
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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