Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sexual Health of Spinal Cord Injured Females (SexSIFem)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02398331
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Standardised information and education on sexuality in women with spinal cord injury Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Female Sexual Function Index (FSFI) 12 months after returning home [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398331


Contacts
Layout table for location contacts
Contact: François Giuliano, MD, PhD +33(0)147107832 francois.giuliano@uvsq.fr

Locations
Layout table for location information
France
Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital Recruiting
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: François Giuliano, MD, PhD Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02398331     History of Changes
Other Study ID Numbers: P130912
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: November 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Spinal cord injuries
Sexual function
Sexual response
Sexuality
Women

Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries