Sexual Health of Spinal Cord Injured Females

Assistance Publique - Hôpitaux de Paris40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Standardised information and education on sexuality in women with spinal cord injuryOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, France

Outcomes

Primary Outcomes

Female Sexual Function Index (FSFI) 12 months after returning home

Time frame: 12 months

Secondary Outcomes

Hospital anxiety and depression scale (HAD)

Time frame: 12 months

London Handicap Scale (LHS)

Time frame: 12 months

Expectations of women in terms of care

Time frame: 12 months

Stability or change of sexual partner

Time frame: 12 months

Data from ClinicalTrials.gov

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