Male Sexual DysfunctionNCT02908867
Therapeutic Strategies in Sexual Function
An observational study of Male Sexual Dysfunction and Spinal Cord Injury, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Male Sexual Dysfunction, Spinal Cord Injury
- What is being tested?
- Therapeutic Strategies
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to May 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 involving 24 men with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). 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
- heterosexual
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Strategies in Sexual Function of Men With Spinal Cord Injury
Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions.
Read the detailed description
Methods: This is a descriptive observational study involving 24 men with a mean age of 32.62 (CI 28.65 to 36.60), with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). The subjects underwent neurological evaluation in accordance with the guidelines of the International Standards for Neurological Examination and Functional classification of Spinal Cord Injury (ISNCSCI), the American Spinal Injury Association (ASIA), assessment of sexual function through the Erectile Function of International Index (IIEF) and answered a semi-structured form to identify therapeutic strategies used in sexual function. To collect information about medicinal plants, a search was made in the surroundings of public markets located in the Metropolitan Region of Recife (PE).
- Conditions
- Male Sexual Dysfunction, Spinal Cord Injury
- Being tested
- Therapeutic Strategies
- Keywords
- Sexuality, Spinal cord injuries, Complementary Therapies, Medicinal plants
- Medical subject headings
- Spinal Cord Injuries, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic StrategiesOther
Using questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic strategies group | To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions, mainly medicinal plants. Receives: Other: Therapeutic Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Strategies
Therapeutic Strategies assessed by semi structured form in public market
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 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 posted21 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Sexual DysfunctionStudies 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
- 24 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
- NCT02908867
- Sponsor's protocol ID
- THERAPEUTIC STRATEGIES SCI
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2016
- Last updated
- 21 Sep 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 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategies in Sexual Function of Men With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02908867
- Acronym / sponsor ID
- THERAPEUTIC STRATEGIES SCI
- Conditions
- Male Sexual Dysfunction, Spinal Cord Injury
- Keywords
- Sexuality, Spinal cord injuries, Complementary Therapies, Medicinal plants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Sep 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.
Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions.
Detailed description
Methods: This is a descriptive observational study involving 24 men with a mean age of 32.62 (CI 28.65 to 36.60), with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). The subjects underwent neurological evaluation in accordance with the guidelines of the International Standards for Neurological Examination and Functional classification of Spinal Cord Injury (ISNCSCI), the American Spinal Injury Association (ASIA), assessment of sexual function through the Erectile Function of International Index (IIEF) and answered a semi-structured form to identify therapeutic strategies used in sexual function. To collect information about medicinal plants, a search was made in the surroundings of public markets located in the Metropolitan Region of Recife (PE).
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic strategies group | – | Other: Therapeutic StrategiesTo know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions, mainly medicinal plants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study involving 24 men with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). 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 (4 listed)
- clinical diagnosis of traumatic spinal cord injury
- injury time less than six months
- heterosexual
- 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 |
|---|---|---|
| Therapeutic StrategiesUsing questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form | Other | Therapeutic strategies group |
Primary outcome
Therapeutic Strategies
Time frame: one day
Therapeutic Strategies assessed by semi structured form in public market
3 secondary outcomes
level of neurological lesion
Time frame: one day
Degree of 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 21 Sep 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 Male Sexual Dysfunction and 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 4 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 21 Sep 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?
Therapeutic Strategies (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 21 Sep 2016.