Sexual Health of Spinal Cord Injured Females (SexSIFem)
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|ClinicalTrials.gov Identifier: NCT02398331|
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: Standardised information and education on sexuality in women with spinal cord injury||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|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|
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:
No Intervention: Control arm
Usual care (no structured information or education on sexuality)
- Female Sexual Function Index (FSFI) 12 months after returning home [ Time Frame: 12 months ]
- Hospital anxiety and depression scale (HAD) [ Time Frame: 12 months ]
- London Handicap Scale (LHS) [ Time Frame: 12 months ]
- Expectations of women in terms of care [ Time Frame: 12 months ]
- Stability or change of sexual partner [ Time Frame: 12 months ]
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
|Contact: François Giuliano, MD, PhD||+33(0)email@example.com|
|Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital||Recruiting|
|Garches, Hauts-de-Seine, France, 92380|
|Principal Investigator:||François Giuliano, MD, PhD||Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France|