Sexual Health of Spinal Cord Injured Females (SexSIFem)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Other: Standardised information and education on sexuality in women with spinal cord injury

Study type

Interventional

Funder types

Other

Identifiers

NCT02398331

P130912

Details and patient eligibility

About

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.

Full description

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

Enrollment

40 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)