Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury

Completed

• Conditions: Male Sexual Dysfunction; Spinal Cord Injury

• Registration Number: NCT02860689
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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

Detailed Description

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.

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
• Last Update Submitted: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Depression	one day	Depression assessed by Beck Depression Inventary (BDI)
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

Trial Locations

Locations (1)

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