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Effects of Spinal Cord Injury on Female Sexual Response

Primary Purpose

Female Sexual Dysfunction, Multiple Sclerosis, Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sympathetic manipulation on sexual arousal in women
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Female Sexual Dysfunction focused on measuring sexual response, sexual dysfunction in females, spinal cord injury

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: MS or SCI Normal menstrual periods Normal hand function Have ability to feel sensation from lower abdomen to upper thigh region. Exclusion Criteria: Pregnant Menopausal

Sites / Locations

  • The University of Alabama at BirminghamRecruiting

Outcomes

Primary Outcome Measures

Our central hypothesis are:
1) In females the SNS regulates psychogenic genital vasocongestion 2) In females the orgasmic reflex requires the presence of an intact sacral spinal cord, 3) In females a pattern generator is responsible for the orgasmic reflex.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
October 13, 2006
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00142714
Brief Title
Effects of Spinal Cord Injury on Female Sexual Response
Official Title
Effects of SCI on Female Sexual Response
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
The long term aims of this project are to 1) Understand the effect of varying degrees and levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new assessment and treatment methods for neurogenic sexual dysfunction in women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Dysfunction, Multiple Sclerosis, Spinal Cord Injury
Keywords
sexual response, sexual dysfunction in females, spinal cord injury

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Sympathetic manipulation on sexual arousal in women
Primary Outcome Measure Information:
Title
Our central hypothesis are:
Title
1) In females the SNS regulates psychogenic genital vasocongestion 2) In females the orgasmic reflex requires the presence of an intact sacral spinal cord, 3) In females a pattern generator is responsible for the orgasmic reflex.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MS or SCI Normal menstrual periods Normal hand function Have ability to feel sensation from lower abdomen to upper thigh region. Exclusion Criteria: Pregnant Menopausal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Spath
Phone
1-866-706-5544
Email
pspath@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marca Sipski, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Spath
Phone
205-934-2088
Email
pspath@uab.edu
First Name & Middle Initial & Last Name & Degree
Marca Sipski, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28899827
Citation
Alexander M, Bashir K, Alexander C, Marson L, Rosen R. Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. Arch Phys Med Rehabil. 2018 Feb;99(2):299-305. doi: 10.1016/j.apmr.2017.09.001. Epub 2017 Sep 9.
Results Reference
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Effects of Spinal Cord Injury on Female Sexual Response

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