- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860637
Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
August 13, 2016 updated by: Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pernambuco
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Recife, Pernambuco, Brazil, +5581
- Josepha Karinne de Oliveira Ferro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual function
Time Frame: one day
|
Sexual function assessed by the International Index of Erectile Function (IIEF)
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one day
|
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
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Josepha KO Ferro, master, Universidade Federal de Pernambuco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 31, 2016
First Submitted That Met QC Criteria
August 4, 2016
First Posted (Estimate)
August 9, 2016
Study Record Updates
Last Update Posted (Estimate)
August 16, 2016
Last Update Submitted That Met QC Criteria
August 13, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spinal Cord and sexuality
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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