Sexual Health of Spinal Cord Injured Females

Spinal Cord Injuries Clinical Trial

— SexSIFem  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398331
• Other study ID #: P130912
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2019

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
France	Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital	Garches	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function Index (FSFI) 12 months after returning home		12 months
Secondary	Hospital anxiety and depression scale (HAD)		12 months
Secondary	London Handicap Scale (LHS)		12 months
Secondary	Expectations of women in terms of care		12 months
Secondary	Stability or change of sexual partner		12 months