NCT02860637

Brief Summary

In addition to the motor and sensory functions, sexual function changes after spinal cord injury and is considered one of the most common problems, ranging from a decrease in sexual desire to disturbances of erection, orgasm and ejaculation. Objective: To assess the impact of the complexity of traumatic spinal cord injury in male sexual function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

July 31, 2016

Last Update Submit

August 13, 2016

Conditions

Keywords

SexualitySpinal cord injuriesPenile erectionerectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • Sexual function

    Sexual function assessed by the International Index of Erectile Function (IIEF)

    one day

Secondary Outcomes (2)

  • Degree of neurological lesion

    one day

  • Level of neurological lesion

    one day

Interventions

Sexual function was assessed by the International Index of Erectile Function (IIEF) and level and degree of injury were determined following the guidelines of the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury.

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Observational study, conducted between March 2015 and ending in January 2016, with males, aged between 18 and 60 years; clinical diagnosis of traumatic spinal cord injury, injury time equal to or greater than six months, heterosexual and sexually active.

You may qualify if:

  • men
  • aged between 18 and 60 years
  • clinical diagnosis of traumatic spinal cord injury
  • injury time equal to or greater than six months
  • heterosexual
  • sexually active.

You may not qualify if:

  • patients with erectile dysfunction attributed to endocrine or metabolic disease order
  • those who underwent surgery as radical prostatectomy or penile implant
  • cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Josepha Karinne de Oliveira Ferro

Recife, Pernambuco, +5581, Brazil

Location

MeSH Terms

Conditions

Spinal Cord InjuriesSexualityErectile Dysfunction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSexual BehaviorBehaviorGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Josepha KO Ferro, master

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psysical Therapist

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 9, 2016

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations