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

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

    • Pernambuco
      • Recife, Pernambuco, Brazil, +5581
        • Josepha Karinne de Oliveira Ferro

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.
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

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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