Spinal Cord InjuriesNCT02958904
Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury
An observational study of Spinal Cord Injuries and Male Sexual Dysfunction, run by Universidade Federal de Pernambuco.
Trial summary
Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Spinal Cord Injuries, Male Sexual Dysfunction
- What is being tested?
- using questionnaires
- How many people
- 44 participants
- Where
- No sites listed yet
- 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
- No healthy volunteers
- Adult
Study population: The study included 44 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.
Who may be able to join
- clinical diagnosis of traumatic spinal cord injury
- injury time less than six months
- sexually active
Who cannot join
- 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
- cognitive impairment
About this study
Official title: Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury
Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.
Read the detailed description
Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.
- Conditions
- Spinal Cord Injuries, Male Sexual Dysfunction
- Being tested
- using questionnaires
- Keywords
- Sexuality, Spinal cord injuries, Erectile dysfunction, depression
- Medical subject headings
- Spinal Cord Injuries, Sexuality, Erectile Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using questionnairesOther
using questionnaires International Index Erectile Function and Beck Depression Inventory.
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
Depressive symptoms assessed by Beck Depression Inventory (BDI)
Measured: one day
Secondary outcomes (3)
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
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
Male Sexual Dysfunction
Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)
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 posted8 Nov 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 InjuriesStudies 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
- 44 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958904
- Sponsor's protocol ID
- Depressive symptoms SCI
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 8 Nov 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 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02958904
- Acronym / sponsor ID
- Depressive symptoms SCI
- Conditions
- Spinal Cord Injuries, Male Sexual Dysfunction
- Keywords
- Sexuality, Spinal cord injuries, Erectile dysfunction, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 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
- 8 Nov 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.
Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.
Detailed description
Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included 44 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.
Key inclusion criteria (3 listed)
- clinical diagnosis of traumatic spinal cord injury
- injury time less than six months
- sexually active
Key exclusion criteria (3 listed)
- 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
- 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 |
|---|---|---|
| using questionnairesusing questionnaires International Index Erectile Function and Beck Depression Inventory. | Other | – |
Primary outcome
depressive symptoms
Time frame: one day
Depressive symptoms assessed by Beck Depression Inventory (BDI)
3 secondary outcomes
Level of neurological lesion
Time frame: one day
Degree of neurological lesion
Time frame: one day
Male Sexual Dysfunction
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 8 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Male Sexual Dysfunction, run by Universidade Federal de Pernambuco.
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 3 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
depressive symptoms (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 8 Nov 2016.