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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02860689
Other study ID # Spinal Cord 2016
Secondary ID
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


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
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