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

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT02860637
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-01
• Study Completion: 2016-07
• Study First Submitted: 2016-07-31
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Submitted: 2016-08-13
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual function	one day	Sexual function assessed by the International Index of Erectile Function (IIEF)

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

Trial Locations

Locations (1)

Josepha Karinne de Oliveira Ferro; 🇧🇷 Recife, Pernambuco, Brazil