Multiple Sclerosis, Relapsing Remitting Clinical Trial
Official title:
Observational Study to Determine the Relationship Between the Degree of Disability and the Presence of Sexual Dysfunction and Between Sexual Dysfunction and the Quality of Life in Patients With Multiple Sclerosis (RRMS)
This is an observational, prospective, non-interventional, non-controlled study planned to
be conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).
The purpose of this observational study is to determine the correlation between the degree
of disability and sexual dysfunction; and between the sexual dysfunction and the quality of
life (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.
Multiple sclerosis, like most of the chronic diseases, can affect the sexuality of those who
suffer from it. This situation has an evident and marked impact on the QoL of the subjects
and his/her partner, and causes conflict in the relationship, with high levels of mutual
dissatisfaction.
The impact that the duration of the disease or the degree of disability have on the level of
sexual dysfunction is not clear. However, the possible organic and state of mind causes of
the sexual dysfunction makes us think that the degree of disability is a crucial factor in
the genesis and duration of the symptoms in the sexual area. The frequency with which the
sexual dysfunction is detected or referred in these subjects is variable.
The sexual dysfunction in subjects with MS is typically characterized by a decreased libido,
erectile dysfunction and ejaculation disorders in men, and decreased lubrication and
anorgasmia in women. The most commonly detected problems are the erectile dysfunction and/or
lack of sexual interest in men and lack of interest, decreased libido and orgasmic disorder
in women.
This observational study aims to assess a population of subjects with MS that show symptoms
of sexual dysfunction, in order to determine the relationship, if any, between the severity
of the general disability and the incidence of sexual dysfunction. At the same time, this
epidemiologic study aims to measure the impact the sexual dysfunction generates in the
quality of life of subjects with MS.
The data to be obtained could contribute to a better understanding of the relationship
between the studied variables and, eventually, to alert the treating doctors about the
incidence of these morbid associations.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once
the recruiting time is over, the collection of data will continue during the full 24 months
period that was planned.
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Observational Model: Cohort, Time Perspective: Prospective
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