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OpenTrials
Completed

NCT Number: NCT02860637

Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function

In addition to the motor and sensory functions, sexual function changes after spinal cord injury and is considered one of the most common problems, ranging from a decrease in sexual desire to disturbances of erection, orgasm and ejaculation.

Objective: To assess the impact of the complexity of traumatic spinal cord injury in male sexual function.

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Key information

Conditions

Spinal Cord Injury 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 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

Methods: Observational study (CEAC 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 (IIEF) 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. Data were collected after at least six months of injury in referral hospitals. Descriptive statistics and bivariate analysis were applied to observe the association between sexual function and complexity of the lesion, with a 0.05 significance level.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • men
  • aged between 18 and 60 years
  • clinical diagnosis of traumatic spinal cord injury
  • injury time equal to or greater than six months
  • heterosexual
  • sexually active.

Exclusion criteria

  • patients with erectile dysfunction attributed to endocrine or metabolic disease order
  • those who underwent surgery as radical prostatectomy or penile implant
  • cognitive impairment.

Treatment and study plan

questionnaires

Other

Sexual function was assessed by the International Index of Erectile Function (IIEF) 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.

Primary outcomes

  1. Sexual function

    Time frame: one day

    Sexual function assessed by the International Index of Erectile Function (IIEF)

Secondary outcomes

  1. 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

  2. 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

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 16, 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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