Sexual Health of Spinal Cord Injured Females

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact on sexuality in women with a spinal cord injury, twelve months after their first return to home, of a program including structured information and education on sexuality, delivered 6 months after their first return to home.

Detailed Description
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Multicentre, prospective study, aiming to assess the effect on sexuality of an information and education program in women with spinal cord injury. Included patients will be women hospitalized for initial rehabilitation, and will be included two weeks before their first return to home. Socio-demographic data, diagnosis and etiology, secondary conditions, treatment, comorbidities and expectations towards rehabilitation care will be assessed at inclusion. At M3 Patients will be randomized in either the intervention arm or the control arm. Patients enrolled in the intervention arm will benefit from a standardised information and education consultation on physiology of sexual response 6 months after their return home. Patients enrolled in the control arm will undergo the same follow-up but will only have the usual unstructured and unformalized information provided by the clinical team. At M3, M6, M12 secondary conditions , sexual function index (FSFI), social integration (LHS), treatment and expectations towards rehabilitation care will be assessed

Official Title
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Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Standardised information and education on sexuality in women with spinal cord injury


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal cord injury including cauda equina injury of traumatic etiology or not Hospitalization for initial post-injury rehabilitation in a study center First return at home scheduled within the 14 days following inclusion date Understanding of the French language allowing to answer questionnaires Affiliation to health insurance Written informed consent Exclusion Criteria: Full recovery of sensory-motor functions (AISE) Associated brain injury Psychiatric disease previously diagnosed, excepted treated and remitting mood disorders Patients with tutorship / guardianship Spinal cord injury of malignant origin Spinal cord injury associated with multiple sclerosis Anticipated loss-to-follow-up (patient moving outside of the usual hospital catchment area)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm<br>Standardised information and education on sexuality in women with spinal cord injury | Other: Standardised information and education on sexuality in women with spinal cord injury<br>* Program of information and education on the physiology of sexual response in women with spinal cord injury 6 months after their first return to home: Educational footage Clinical neurological examination with educational aim Structured consultation providing information on the physiology of sexual response in women with spinal cord injury<br>|
| No Intervention: Control arm<br>Usual care (no structured information or education on sexuality) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function Index (FSFI) 12 months after returning home |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital anxiety and depression scale (HAD) |  | 12 months | 
| London Handicap Scale (LHS) |  | 12 months | 
| Expectations of women in terms of care |  | 12 months | 
| Stability or change of sexual partner |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injuries, Sexual function, Sexual response, Sexuality, Women