- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02908867
Therapeutic Strategies in Sexual Function
September 20, 2016 updated by: Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pernambuco
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Recife, Pernambuco, Brazil, +5581
- Josepha Karinne de Oliveira Ferro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- clinical diagnosis of traumatic spinal cord injury
- injury time less than six months
- heterosexual
- sexually active
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Therapeutic strategies group
To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions, mainly medicinal plants.
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Using questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic Strategies
Time Frame: one day
|
Therapeutic Strategies assessed by semi structured form in public market
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
level of neurological lesion
Time Frame: one day
|
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
|
Degree of lesion
Time Frame: one day
|
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
|
Male sexual dysfunction
Time Frame: one day
|
Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Josepha KO Ferro, master, Universidade Federal de Pernambuco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
September 18, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimate)
September 21, 2016
Study Record Updates
Last Update Posted (Estimate)
September 21, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THERAPEUTIC STRATEGIES SCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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