Spinal Cord InjuriesSexSIFemNCT02398331
Sexual Health of Spinal Cord Injured Females
A study testing Standardised information and education on sexuality in women with spinal cord injury in people with Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Standardised information and education on sexuality in women with spinal cord injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
Garches, Hauts-de-Seine, 92380
About this study
Official title: 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.
Read the 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
- Conditions
- Spinal Cord Injuries
- Being tested
- Standardised information and education on sexuality in women with spinal cord injury
- Keywords
- Spinal cord injuries, Sexual function, Sexual response, Sexuality, Women
- Medical subject headings
- Spinal Cord Injuries, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised information and education on sexuality in women with spinal cord injuryOther
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
| Study group | Role | What they receive |
|---|---|---|
| arm | Experimental | Standardised information and education on sexuality in women with spinal cord injury Receives: Other: Standardised information and education on sexuality in women with spinal cord injury |
| Control arm | No intervention | Usual care (no structured information or education on sexuality) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI) 12 months after returning home
Measured: 12 months
Secondary outcomes (4)
Hospital anxiety and depression scale (HAD)
Measured: 12 months
London Handicap Scale (LHS)
Measured: 12 months
Expectations of women in terms of care
Measured: 12 months
Stability or change of sexual partner
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Giuliano, MD, PhD, Principal investigator, Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398331
- Sponsor's protocol ID
- P130912
- Acronym
- SexSIFem
- Status last verified
- Nov 2017
- First submitted
- 20 Mar 2015
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02398331
- Acronym / sponsor ID
- SexSIFem / P130912
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injuries, Sexual function, Sexual response, Sexuality, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm | Experimental | Other: Standardised information and education on sexuality in women with spinal cord injuryStandardised information and education on sexuality in women with spinal cord injury |
| Control arm | No intervention | –Usual care (no structured information or education on sexuality) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised information and education on sexuality in women with spinal cord injuryProgram 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 | Other | arm |
Primary outcome
Female Sexual Function Index (FSFI) 12 months after returning home
Time frame: 12 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Giuliano, MD, PhD principal investigator
Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardised information and education on sexuality in women with spinal cord injury in people with Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) 12 months after returning home (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.