NCT02908867

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 18, 2016

Last Update Submit

September 20, 2016

Conditions

Keywords

SexualitySpinal cord injuriesComplementary TherapiesMedicinal plants

Outcome Measures

Primary Outcomes (1)

  • Therapeutic Strategies

    Therapeutic Strategies assessed by semi structured form in public market

    one day

Secondary Outcomes (3)

  • level of neurological lesion

    one day

  • Degree of lesion

    one day

  • Male sexual dysfunction

    one day

Study Arms (1)

Therapeutic strategies group

To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions, mainly medicinal plants.

Other: Therapeutic Strategies

Interventions

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

Therapeutic strategies group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • clinical diagnosis of traumatic spinal cord injury
  • injury time less than six months
  • heterosexual
  • sexually active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Josepha Karinne de Oliveira Ferro

Recife, Pernambuco, +5581, Brazil

Location

MeSH Terms

Conditions

Spinal Cord InjuriesSexuality

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSexual BehaviorBehavior

Study Officials

  • Josepha KO Ferro, master

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree

Study Record Dates

First Submitted

September 18, 2016

First Posted

September 21, 2016

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations