Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors

Status unknownNot a drug-phase studyMS (type not specified)NCT03154801

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Paramedical care

What it measured

Main measures

  • Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

    Inclusion and 3 months

    Bladder, bowel and sexual function

Other measures (13)

  • Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)

    Inclusion and 6-months

    Bladder, bowel and sexual function
  • Change of HAD scale (Hospital Anxiety and Depression)

    Inclusion and 3 months

    Mood and sleep
  • Change of HAD scale (Hospital Anxiety and Depression)

    Inclusion and 6 months

    Mood and sleep
  • Change of Rosenberg's Self-esteem Scale

    Inclusion and 3 months

  • Change of Rosenberg's Self-esteem Scale

    Inclusion and 6 months

  • Change of Quality of life scale

    Inclusion and 3 months

    Quality of life (reported by participants)
  • Change of Quality of life scale

    Inclusion and 6 months

    Quality of life (reported by participants)
  • Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)

    Inclusion and 3 months

    Quality of life (reported by participants)
  • Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)

    Inclusion and 6 months

    Quality of life (reported by participants)
  • Change of SEP59 scale (Sclérose En Plaques)

    Inclusion and 3 months

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

1. Any major patient, followed in the GHPSCF (Groupe Hospitalier Pitié-Salpêtrière Charles Foix) neurology department 2 for a diagnosis of low grade glioma or anaplastic glioma with loss 1p / 19q sub-reserve histo-molecular confirmation after national reading (POLA) and presenting: * An MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) questionnaire with at least one of the items rated "4" or "5" and * A HAD (Hospital Anxiety and Depression) questionnaire (depression component) with a score ≤ 11 2. Any major patient with MS(Multiple Sclerosis), followed in the GHPSCF Department of Neurology: * With an EDSS (Expanded Disability Status Scale) greater than or equal to 1 and * An MSISQ15 questionnaire with at least one of the items rated "4" or "5". * A HAD questionnaire (depression component) with a score ≤ 11 3. Signature of informed consent 4. Patient affiliated to a social security system

Exclusion criteria

1. Minor patients 2. Pregnant women 3. Patients who do not understand and / or speak French and / or are unable to sign consent 4. Patients with neurological impairment 5. Patients with chronic sexual disorders who have already received treatment. 6. Patients with a HAD score (depression component) greater than 11 7. Patients with MS who had a corticosteroid-treated outbreak in the last two months. 8. Patients with low-grade glioma with clinical and / or radiological scalability during the last three months 9. Any patient whose alteration of the general state would not allow to follow the program. 10. Patients under legal protection For patient's partners: Inclusion criteria: 1. Any patient partner, whose patient has wished to participate and who has accepted. 2. Signing of informed consent Non-Inclusion Criteria: 1. Minor partners 2. Pregnant women 3. Any person who does not understand and / or speak French and / or is unable to sign the consent 4. Partners under legal protection

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.

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History

    1. Started

      Jul 2017

    2. Main results due

      Jan 2022

    3. Finished

      Jul 2022

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