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Completed

NCT Number: NCT02398331

Sexual Health of Spinal Cord Injured Females

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, 92380, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Hospital anxiety and depression scale (HAD)

    Time frame: 12 months

  2. London Handicap Scale (LHS)

    Time frame: 12 months

  3. Expectations of women in terms of care

    Time frame: 12 months

  4. Stability or change of sexual partner

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SexSIFem

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2015
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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