Therapeutic Strategies in Sexual Function

Spinal Cord Injury Clinical Trial

Official title:

Therapeutic Strategies in Sexual Function of Men With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908867
• Other study ID #: THERAPEUTIC STRATEGIES SCI
• 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

Related Conditions & MeSH terms

• Male Sexual Dysfunction
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

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