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Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02860689
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco

Brief Summary:
Objective: To analyze the association between sexual function of men with spinal cord injury with possible predictive factors for dysfunction.

Condition or disease Intervention/treatment
Male Sexual Dysfunction Spinal Cord Injury Other: using questionnaires - International Index Erectile Function

Detailed Description:
Method: Observational study (CAAE 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 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. Descriptive statistical techniques were applied and multivariate analysis using logistic regression adjusted to observe the association between factors, with 0.05 significance level.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 45 participants
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: using questionnaires - International Index Erectile Function
    using questionnaires


Primary Outcome Measures :
  1. Male Sexual Dysfunction [ Time Frame: one day ]
    Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)


Secondary Outcome Measures :
  1. 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

  2. Degree of neurological 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

  3. Depression [ Time Frame: one day ]
    Depression assessed by Beck Depression Inventary (BDI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study included 45 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.
Criteria

Inclusion Criteria:

  • clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and 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 and cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860689


Locations
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Brazil
Josepha Karinne de Oliveira Ferro
Recife, Pernambuco, Brazil, +5581
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Josepha KO Ferro, master Universidade Federal de Pernambuco
Additional Information:

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Responsible Party: Josepha Karinne de Oliveira Ferro, Physical Therapist, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02860689    
Other Study ID Numbers: Spinal Cord 2016
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Josepha Karinne de Oliveira Ferro, Universidade Federal de Pernambuco:
Sexuality
Spinal cord injuries
Penile erection
erectile dysfunction
Psychological Sexual Dysfunctions
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System