- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07677852
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Saskia BRESCH
- 전화번호: 04 92 03 83 20
- 이메일: Bresch.s@chu-nice.fr
연구 장소
-
-
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Nice, 프랑스, 06000
- Nice University Hospital
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수석 연구원:
- Saskia Bresch
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연락하다:
- Saskia BRESCH
- 전화번호: 04 92 03 83 20
- 이메일: Bresch.s@chu-nice.fr
-
Paris, 프랑스, 75000
- APHP and Myology institute
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연락하다:
- BIRNBAUM Simone
- 전화번호: 33 1 42 16 58 79
- 이메일: s.birnbaum@institut-myologie.org
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수석 연구원:
- Sophie DEMERET
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Myasthenic patient with genitourinary and sphincter disorders
|
no intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Classification of Sexual Dysfunction in Patients with Generalized Autoimmune Myasthenia
기간: At inclusion
|
The sexual complaints questionnaire (QPS questionnaire) assesses sexual complaints over the past six months-on a scale of 0 to 9
|
At inclusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of Bladder and Sphincter Disorders
기간: at inclusion
|
Urinary Symptoms Questionnaire score from 0 to 21
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at inclusion
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Evaluation of Anorectal Disorders
기간: 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
기간: at inclusion
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Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire - score 0 to 24
|
at inclusion
|
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Impact of Myasthenia Gravis on Quality of Life
기간: 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
기간: 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
기간: 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
|
at inclusion
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-PP-12
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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