Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
1 other identifier
observational
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 31, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedAugust 16, 2016
August 1, 2016
10 months
July 31, 2016
August 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sexual function
Sexual function assessed by the International Index of Erectile Function (IIEF)
one day
Secondary Outcomes (2)
Degree of neurological lesion
one day
Level of neurological lesion
one day
Interventions
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.
Eligibility Criteria
Observational study, conducted between March 2015 and ending in January 2016, with males, aged between 18 and 60 years; clinical diagnosis of traumatic spinal cord injury, injury time equal to or greater than six months, heterosexual and sexually active.
You may qualify if:
- 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.
You may not qualify if:
- patients with erectile dysfunction attributed to endocrine or metabolic disease order
- those who underwent surgery as radical prostatectomy or penile implant
- cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Josepha Karinne de Oliveira Ferro
Recife, Pernambuco, +5581, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josepha KO Ferro, master
Universidade Federal de Pernambuco
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psysical Therapist
Study Record Dates
First Submitted
July 31, 2016
First Posted
August 9, 2016
Study Start
March 1, 2015
Primary Completion
January 1, 2016
Study Completion
July 1, 2016
Last Updated
August 16, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share