Sexual and Urinary Dysfunctions in Generalized Myasthenia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum age of 18 years at the time the informed consent form is obtained.

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

Disqualifiers

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.

Trial population

Myasthenic patients

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • No intervetion

    Other intervention

    no intervention

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Myasthenic patient with genitourinary and sphincter disorders1 intervention

Trial outcomes

Primary outcomes

1

Classification of Sexual Dysfunction in Patients with Generalized Autoimmune Myasthenia

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

Secondary outcomes

1

Assessment of Bladder and Sphincter Disorders

Urinary Symptoms Questionnaire score from 0 to 21

Time frame
at inclusion
2

Evaluation of Anorectal Disorders

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
3

The Impact of Myasthenia on Daily Life

Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire - score 0 to 24

Time frame
at inclusion
4

Impact of Myasthenia Gravis on Quality of Life

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

Other outcomes

Sponsors and contacts

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