Sexual Health of Spinal Cord Injured Females

NCT ID: NCT02398331

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-10-31

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

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Control arm

Usual care (no structured information or education on sexuality)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Giuliano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France

Locations

Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, France

Countries

France

Other Identifiers

P130912

Identifier Type: -

Identifier Source: org_study_id