Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02860637
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco

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.


Condition or disease Intervention/treatment
Spinal Cord Injury Other: Questionnaires

Detailed Description:
Methods: Observational study (CEAC 41221414.5.0000.5208) conducted with 45 men, mean age 34 (CI 31.5 to 37.1), with spinal cord injury and active sex life. 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. Data were collected after at least six months of injury in referral hospitals. Descriptive statistics and bivariate analysis were applied to observe the association between sexual function and complexity of the lesion, with a 0.05 significance level.

Layout table for study information
Study Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Cross-Sectional
Official Title: Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Questionnaires
    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.


Primary Outcome Measures :
  1. Sexual function [ Time Frame: one day ]
    Sexual function assessed by the International Index of Erectile Function (IIEF)


Secondary Outcome Measures :
  1. Degree of neurological lesion [ Time Frame: one day ]
    Degree of neurological lesion assessed by ASIA Impairment Scale (AIS) according to the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury

  2. Level of neurological lesion [ Time Frame: one day ]
    Level of neurological lesion assessed by ASIA Impairment Scale (AIS) according to the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860637


Locations
Layout table for location information
Brazil
Josepha Karinne de Oliveira Ferro
Recife, Pernambuco, Brazil, +5581
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Layout table for investigator information
Principal Investigator: Josepha KO Ferro, master Universidade Federal de Pernambuco

Layout table for additonal information
Responsible Party: Josepha Karinne de Oliveira Ferro, Psysical Therapist, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02860637     History of Changes
Other Study ID Numbers: Spinal Cord and sexuality
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco:
Sexuality
Spinal cord injuries
Penile erection
erectile dysfunction

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System