Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury

Completed

• Conditions: Spinal Cord Injuries; Male Sexual Dysfunction

• Registration Number: NCT02958904
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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

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 Timeline

• Study Start: 2015-03
• Primary Completion: 2016-01
• Study Completion: 2016-07
• Status Verified: 2016-11
• Study First Submitted: 2016-11-06
• Study First Submitted QC: 2016-11-07
• Last Update Submitted: 2016-11-07
• Study First Posted: 2016-11-08
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
depressive symptoms	one day	Depressive symptoms assessed by Beck Depression Inventory (BDI)

Secondary Outcome Measures

Name	Time	Method
Level of neurological lesion	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
Degree of neurological lesion	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
Male Sexual Dysfunction	one day	Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)