Penile Vibratory Stimulation in Muscle Spasticity and Spinal Cord Injury - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Penile Vibratory Stimulation

Detailed Description

Spinal cord injury can result in mild to severe muscle spasms that can both inhibit functional capability and increase the likelihood of injury due to fall. Anecdotal reports and a recent study suggest that triggering the ejaculatory reflex in men with vibratory stimulation can result in a significant decrease in spasm activity over a period of 2 to 42 hours. This study examines the effects of penile vibratory stimulation on spasticity when conducted daily in the home setting.

Study Type

Interventional

Enrollment

30

Phase

Not Applicable

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

United States
- Florida
  - Miami, Florida, United States, 33125
    - Miami Veterans Affairs Medical Center

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Diagnosed with a traumatic spinal cord injury

Level of injury is at T6 or below
Injured at least 6 months prior to study enrollment
Male, aged 18 to 70 years
Spasticity to a degree that either anti-spasticity medications have been or are being used or current spasticity is at 2 or greater on the Ashworth scale specifically for the quadriceps muscle group (knee flexion)

Exclusion Criteria:

Medical instability
Subjects may not use Cialis
Use of Viagra, Levitra, Caverject, or vacuum constriction devices is restricted to no less than 8 hours prior to daily vibratory therapy
Recent history of autonomic dysreflexia secondary to sexual stimulation
Presence of intrathecal Baclofen pumps
Inability or unwillingness to use the therapy daily

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

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Spasticity in the lower extremities will be scored per the
Ashworth scale at each weekly visit. Additionally,
subjects will record their daily spasm frequency on a 5
point scale in the form of a daily questionnaire. Intra
and inter-visit indicies of spas.

Secondary Outcome Measures

Outcome Measure
Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

Principal Investigator: Angelo E Gousse, MD, Miami VA Medical Center Urology Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2002

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria