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The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Muscle Spasticity
Spinal Cord Injury

Treatments

Procedure: Penile Vibratory Stimulation

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00223873
7927-09

Details and patient eligibility

About

The purpose of this study is to determine the effect of penile vibratory stimulation on the muscle spasticity of men with chronic spinal cord injury.

Full 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.

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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