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CompletedNCT00223873Updated Jan 21, 2009

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

An interventional study of Penile Vibratory Stimulation in Spinal Cord Injury and Muscle Spasticity, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
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Study summary

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.

Read the 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.

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Conditions studied

  • Spinal Cord Injury
  • Muscle Spasticity

Keywords

  • Penile Vibratory Stimulation
  • Muscles Spasticity
  • Spasms
  • Ferti Care Vibrator
  • Antispasmotic treatment
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 30 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • ProcedurePenile Vibratory Stimulation
06

What researchers measure

Primary outcomes

  1. Spasticity in the lower extremities will be scored per the

  2. Ashworth scale at each weekly visit. Additionally,

  3. subjects will record their daily spasm frequency on a 5

  4. point scale in the form of a daily questionnaire. Intra

  5. and inter-visit indicies of spas.

Secondary outcomes

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

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Study locations

1 site
  • Miami Veterans Affairs Medical Center
    Miami, Florida 33125, United States
08

References and documents

Publications

  • Maynard FM, Karunas RS, Waring WP 3rd. Epidemiology of spasticity following traumatic spinal cord injury. Arch Phys Med Rehabil. 1990 Jul;71(8):566-9. PubMed 2369291 ↗
  • Zierski J, Muller H, Dralle D, Wurdinger T. Implanted pump systems for treatment of spasticity. Acta Neurochir Suppl (Wien). 1988;43:94-9. doi: 10.1007/978-3-7091-8978-8_21. PubMed 3213666 ↗
  • Young RR, Delwaide PJ. Drug therapy: spasticity (first of two parts). N Engl J Med. 1981 Jan 1;304(1):28-33. doi: 10.1056/NEJM198101013040107. No abstract available. PubMed 6448959 ↗
  • Penn RD, Savoy SM, Corcos D, Latash M, Gottlieb G, Parke B, Kroin JS. Intrathecal baclofen for severe spinal spasticity. N Engl J Med. 1989 Jun 8;320(23):1517-21. doi: 10.1056/NEJM198906083202303. PubMed 2657424 ↗
  • Knutsson E, Lindblom U, Martensson A. Plasma and cerebrospinal fluid levels of baclofen (Lioresal) at optimal therapeutic responses in spastic paresis. J Neurol Sci. 1974 Nov;23(3):473-84. doi: 10.1016/0022-510x(74)90163-4. No abstract available. PubMed 4154365 ↗
  • Ochs G, Struppler A, Meyerson BA, Linderoth B, Gybels J, Gardner BP, Teddy P, Jamous A, Weinmann P. Intrathecal baclofen for long-term treatment of spasticity: a multi-centre study. J Neurol Neurosurg Psychiatry. 1989 Aug;52(8):933-9. doi: 10.1136/jnnp.52.8.933. PubMed 2487035 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00223873
Lead sponsor
US Department of Veterans Affairs
First posted
Sep 22, 2005
Start date
Nov 2002
Completion
Jul 2006
Last update
Jan 21, 2009

Study contacts

Angelo E Gousse, MD
principal investigator · Miami VA Medical Center Urology Service
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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