Spinal Cord InjuryNCT02860637
Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
An observational study of Spinal Cord Injury, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Questionnaires
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- patients with erectile dysfunction attributed to endocrine or metabolic disease order
- those who underwent surgery as radical prostatectomy or penile implant
- cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Questionnaires
- Keywords
- Sexuality, Spinal cord injuries, Penile erection, erectile dysfunction
- Medical subject headings
- Spinal Cord Injuries, Sexuality, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function
Sexual function assessed by the International Index of Erectile Function (IIEF)
Measured: one day
Secondary outcomes (2)
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
Measured: one day
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco
- Investigators
- Josepha KO Ferro, master, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860637
- Sponsor's protocol ID
- Spinal Cord and sexuality
- Status last verified
- Aug 2016
- First submitted
- 31 Jul 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
- ClinicalTrials.gov ID
- NCT02860637
- Acronym / sponsor ID
- Spinal Cord and sexuality
- Conditions
- Spinal Cord Injury
- Keywords
- Sexuality, Spinal cord injuries, Penile erection, erectile dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- men
- aged between 18 and 60 years
- clinical diagnosis of traumatic spinal cord injury
- injury time equal to or greater than six months
- heterosexual
Key exclusion criteria (3 listed)
- patients with erectile dysfunction attributed to endocrine or metabolic disease order
- those who underwent surgery as radical prostatectomy or penile implant
- cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesSexual 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. | Other | – |
Primary outcome
Sexual function
Time frame: one day
Sexual function assessed by the International Index of Erectile Function (IIEF)
2 secondary outcomes
Degree of neurological lesion
Time frame: one day
Level of neurological lesion
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josepha KO Ferro, master principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.