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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02908867
Other study ID # THERAPEUTIC STRATEGIES SCI
Secondary ID
Status Completed
Phase N/A
First received September 18, 2016
Last updated September 20, 2016
Start date March 2015
Est. completion date May 2016

Study information

Verified date September 2016
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions.


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).


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility 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 Design

Time Perspective: Cross-Sectional


Intervention

Other:
Therapeutic Strategies
Using questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form

Locations

Country Name City State
Brazil Josepha Karinne de Oliveira Ferro Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic Strategies Therapeutic Strategies assessed by semi structured form in public market one day No
Secondary 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 one day No
Secondary 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 one day No
Secondary Male sexual dysfunction Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF) one day No
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