Sexual Health of Spinal Cord Injured Females | NCT02398331

Studies
Sexual Health of Spinal Cord Injured Females

NCT02398331

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Feb 25, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Spinal Cord Injuries

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015Actual

Primary Completion Date

Oct 2019Actual

Completion Date

Oct 2019Actual

First Submitted Date

Mar 20, 2015

First Submission Date that Met QC Criteria

Mar 20, 2015

First Posted Date

Mar 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2020

Last Update Posted Date

Feb 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
arm	Experimental	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
Control arm	No Intervention	Usual care (no structured information or education on sexuality)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Female Sexual Function Index (FSFI) 12 months after returning home		12 months

Secondary Outcomes

Measure	Description	Time Frame
Hospital anxiety and depression scale (HAD)		12 months
London Handicap Scale (LHS)		12 months
Expectations of women in terms of care

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Giuliano, MD, PhD	Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital		Garches	Hauts-de-Seine	92380	France

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D019529	Sexuality

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided