Using questionnaires - International Index Erectile Function in Spinal Cord Injury and Male Sexual Dysfunction - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: using questionnaires - International Index Erectile Function

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- Pernambuco
  - Recife, Pernambuco, Brazil, +5581
    - Josepha Karinne de Oliveira Ferro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study included 45 men, aged between 18 and 60 years with a clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and sexually active. The study excluded 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Male Sexual Dysfunction Time Frame: one day	Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day
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	one day
Depression Time Frame: one day	Depression assessed by Beck Depression Inventary (BDI)	one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Investigators

Principal Investigator: Josepha KO Ferro, master, Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)