Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860689
• Other study ID #: Spinal Cord 2016
• Status: Completed
• Phase: N/A
• First received: July 31, 2016
• Last updated: August 4, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Male Sexual Dysfunction
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• using questionnaires - International Index Erectile Function
using questionnaires

Locations

Country	Name	City	State
Brazil	Josepha Karinne de Oliveira Ferro	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Male Sexual Dysfunction	Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)	one day	No
Secondary	Level of neurological lesion	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	one day	No
Secondary	Degree of neurological lesion	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	one day	No
Secondary	Depression	Depression assessed by Beck Depression Inventary (BDI)	one day	No