The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00223873 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: January 21, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injury Muscle Spasticity | Procedure: Penile Vibratory Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury |
Study Start Date : | November 2002 |
Actual Study Completion Date : | July 2006 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223873
United States, Florida | |
Miami Veterans Affairs Medical Center | |
Miami, Florida, United States, 33125 |
Principal Investigator: | Angelo E Gousse, MD | Miami VA Medical Center Urology Service |
Publications:
ClinicalTrials.gov Identifier: | NCT00223873 History of Changes |
Other Study ID Numbers: |
7927-09 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | January 21, 2009 |
Last Verified: | May 2006 |
Keywords provided by VA Office of Research and Development:
Penile Vibratory Stimulation Muscles Spasticity Spasms Ferti Care Vibrator Antispasmotic treatment |
Additional relevant MeSH terms:
Muscle Spasticity Wounds and Injuries Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |
Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms |