Sexual and Urinary Dysfunctions in Generalized Myasthenia

NCT07677852 | Not Yet Recruiting

• 1 other identifier: 25-PP-12
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Myasthenia Gravis (MG)

Keywords

genitourinary and sphincter disorders; Myasthenia gravis

Outcome Measures

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

  At inclusion

Secondary Outcomes (6)

• Assessment of Bladder and Sphincter Disorders

  at inclusion

• Evaluation of Anorectal Disorders

  at inclusion

• The Impact of Myasthenia on Daily Life

  at inclusion

• Impact of Myasthenia Gravis on Quality of Life

  at inclusion

• Health-Related Quality of Life impact

  at inclusion

Study Arms (1)

Myasthenic patient with genitourinary and sphincter disorders

Other: No intervetion

Interventions

No intervetion OTHER

no intervention

Myasthenic patient with genitourinary and sphincter disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Myasthenic patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

Nice University hospital

Nice, 06000, France

Location

APHP and Myology institute

Paris, 75000, France

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Saskia BRESCH

CONTACT

04 92 03 83 20; Bresch.s@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 1, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

FR (2)