NCT02398331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 25, 2020

Status Verified

November 1, 2017

Enrollment Period

4.3 years

First QC Date

March 20, 2015

Last Update Submit

February 24, 2020

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuriesSexual functionSexual responseSexualityWomen

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (4)

  • Hospital anxiety and depression scale (HAD)

    12 months

  • London Handicap Scale (LHS)

    12 months

  • Expectations of women in terms of care

    12 months

  • Stability or change of sexual partner

    12 months

Study Arms (2)

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

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

arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury including cauda equina injury of traumatic etiology or not
  • Hospitalization for initial post-injury rehabilitation in a study center
  • Understanding of the French language allowing to answer questionnaires
  • Affiliation to health insurance
  • Written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, 92380, France

Location

MeSH Terms

Conditions

Spinal Cord InjuriesSexuality

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSexual BehaviorBehavior

Study Officials

  • François Giuliano, MD, PhD

    Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 25, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

February 25, 2020

Record last verified: 2017-11

Locations

FR(1)