Sexual Health of Spinal Cord Injured Females

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Standardised information and education on sexuality in women with spinal cord injury

• Registration Number: NCT02398331
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-25
• Study Start: 2015-07
• Status Verified: 2017-11
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm	Standardised information and education on sexuality in women with spinal cord injury	Standardised information and education on sexuality in women with spinal cord injury

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
London Handicap Scale (LHS)	12 months
Expectations of women in terms of care	12 months
Stability or change of sexual partner	12 months
Hospital anxiety and depression scale (HAD)	12 months

Trial Locations

Locations (1)

Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital; 🇫🇷 Garches, Hauts-de-Seine, France