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Sexual Health of Spinal Cord Injured Females (SexSIFem)

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standardised information and education on sexuality in women with spinal cord injury
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Spinal cord injuries, Sexual function, Sexual response, Sexuality, Women

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

arm

Control arm

Arm Description

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

Usual care (no structured information or education on sexuality)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2015
Last Updated
February 24, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02398331
Brief Title
Sexual Health of Spinal Cord Injured Females
Acronym
SexSIFem
Official Title
Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal cord injuries, Sexual function, Sexual response, Sexuality, Women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm
Arm Type
Experimental
Arm Description
Standardised information and education on sexuality in women with spinal cord injury
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Usual care (no structured information or education on sexuality)
Intervention Type
Other
Intervention Name(s)
Standardised information and education on sexuality in women with spinal cord injury
Intervention Description
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
Primary Outcome Measure Information:
Title
Female Sexual Function Index (FSFI) 12 months after returning home
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hospital anxiety and depression scale (HAD)
Time Frame
12 months
Title
London Handicap Scale (LHS)
Time Frame
12 months
Title
Expectations of women in terms of care
Time Frame
12 months
Title
Stability or change of sexual partner
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Giuliano, MD, PhD
Organizational Affiliation
Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
City
Garches
State/Province
Hauts-de-Seine
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

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Sexual Health of Spinal Cord Injured Females

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