Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958904
• Other study ID #: Depressive symptoms SCI
• Status: Completed
• Phase: N/A
• First received: November 6, 2016
• Last updated: November 7, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Male Sexual Dysfunction
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• using questionnaires
using questionnaires International Index Erectile Function and Beck Depression Inventory.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depressive symptoms	Depressive symptoms assessed by Beck Depression Inventory (BDI)	one day	No
Secondary	Level of neurological lesion	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	No
Secondary	Degree of neurological lesion	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	No
Secondary	Male Sexual Dysfunction	Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)	one day	No