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Completed

NCT Number: NCT02958904

Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury

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

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Key information

Conditions

Spinal Cord Injuries Behavior Behavioral Symptoms Central Nervous System Diseases Depression Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Sexual Dysfunction Male Urogenital Diseases Mental Disorders Nervous System Diseases Sexual Behavior Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexuality Spinal Cord Diseases Trauma, Nervous System Urogenital Diseases Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

using questionnaires

Other

using questionnaires International Index Erectile Function and Beck Depression Inventory.

Primary outcomes

  1. depressive symptoms

    Time frame: one day

    Depressive symptoms assessed by Beck Depression Inventory (BDI)

Secondary outcomes

  1. 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

  2. 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

  3. Male Sexual Dysfunction

    Time frame: one day

    Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 8, 2016
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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