Sexual Health of Spinal Cord Injured Females (SexSIFem)

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Standardised information and education on sexuality in women with spinal cord injury

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Garches, Hauts-de-Seine, France, 92380
      • Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm; Standardised information and education on sexuality in women with spinal cord injury	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
No Intervention: Control arm; Usual care (no structured information or education on sexuality)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Female Sexual Function Index (FSFI) 12 months after returning home	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: François Giuliano, MD, PhD, Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Women; Sexual function; Sexuality; Spinal cord injuries; Sexual response
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: P130912