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Completed

NCT Number: NCT02860689

Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury

Objective: To analyze the association between sexual function of men with spinal cord injury with possible predictive factors for dysfunction.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Josepha Karinne de Oliveira Ferro

Recife, Pernambuco, +5581, Brazil

About this study

Method: Observational study (CAAE 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 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. Descriptive statistical techniques were applied and multivariate analysis using logistic regression adjusted to observe the association between factors, 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 heterosexual and 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 and cognitive impairment

Treatment and study plan

using questionnaires - International Index Erectile Function

Other

using questionnaires

Primary outcomes

  1. Male Sexual Dysfunction

    Time frame: one day

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

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. Depression

    Time frame: one day

    Depression assessed by Beck Depression Inventary (BDI)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2016
Registry last updated
Aug 9, 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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