Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury

November 7, 2016 updated by: Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco

Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury

Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.

Study Type

Observational

Enrollment (Actual)

44

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

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study included 44 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depressive symptoms
Time Frame: one day
Depressive symptoms assessed by Beck Depression Inventory (BDI)
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
Male Sexual Dysfunction
Time Frame: one day
Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

November 6, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Depressive symptoms SCI

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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