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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860637
• Other study ID #: Spinal Cord and sexuality
• Status: Completed
• Phase: N/A
• First received: July 31, 2016
• Last updated: August 13, 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• Questionnaires
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.

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	Sexual function	Sexual function assessed by the International Index of Erectile Function (IIEF)	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	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