NCT02860689

Brief Summary

Objective: To analyze the association between sexual function of men with spinal cord injury with possible predictive factors for dysfunction.

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 9, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

July 31, 2016

Last Update Submit

August 4, 2016

Conditions

Keywords

SexualitySpinal cord injuriesPenile erectionerectile dysfunctionPsychological Sexual Dysfunctions

Outcome Measures

Primary Outcomes (1)

  • Male Sexual Dysfunction

    Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)

    one day

Secondary Outcomes (3)

  • Level of neurological lesion

    one day

  • Degree of neurological lesion

    one day

  • Depression

    one day

Interventions

Eligibility Criteria

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

The study included 45 men, aged between 18 and 60 years with a clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and sexually active. The study excluded patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and cognitive impairment.

You may qualify if:

  • clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and sexually active

You may not qualify if:

  • patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and 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 DysfunctionSexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

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

Study Officials

  • Josepha KO Ferro, master

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical 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 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations