Clinical trial NCT02398331: Sexual Health of Spinal Cord Injured Females
Official title: Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injuries
Sexual function
Sexual response
Sexuality
Women
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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)

Primary outcomes:
measure: Female Sexual Function Index (FSFI) 12 months after returning home
timeFrame: 12 months
Secondary outcomes:
measure: Hospital anxiety and depression scale (HAD)
timeFrame: 12 months
measure: London Handicap Scale (LHS)
timeFrame: 12 months
measure: Expectations of women in terms of care
timeFrame: 12 months
measure: Stability or change of sexual partner
timeFrame: 12 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
state: Hauts-de-Seine
Study officials:
affiliation: Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
name: François Giuliano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: