Clinical Trial: Effects of Endolymphatic Sac Drainage With Steroids for Meniere’s Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Study of Endolymphatic Sac Drainage With or Without Steroids for Intractable Meniere's Disease

Brief Summary: Meniere's disease is a common inner ear disease with an incidence of 15-50 per 100,000 population. Since Meniere’s disease is thought to be triggered by an immune insult to inner ear, we examined intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere’s disease.

Detailed Summary:

Meniere's disease characterized by recurrent attacks of vertigo, fluctuating hearing loss and tinnitus, is a common disease with an incidence of 15-50 per 100,000 population. Some patients with Meniere's disease are strongly prevented from participating in activities of daily life and interaction with their social environment, such as work and schooling, due to frequent attacks of vertigo especially with progressive sensorineural hearing loss, in spite of various kinds of medication. This type of Meniere’s disease is called intractable Meniere’s disease. Although the oto-pathology in Meniere’s temporal bones was revealed in 1938 to be inner ear endolymphatic hydrops, the definitive pathogenesis of Meniere’s disease is still unknown and there is no radical treatment for this disease.

It has, however, been reported that Meniere's disease is usually triggered by immune, metabolic, infectious, traumatic or other insults to the inner ear, associated with a small misplaced malfunctioning endolymphatic sac. Among these insults, immune-mediated responses in the inner ear endo-organs such as the endolymphatic sac, stria vascularis and spiral ligament, are thought to be the main reason for the development of symptoms in Meniere’s disease. Thus, systemic administration and/or local perfusion of corticosteroids into the middle ear have been adopted as an anti-immune or anti-inflammatory therapy for patients with intractable Meniere's disease. These treatments were reported to result in good relief from vertigo and improvement of hearing in some cases. However, these results especially for hearing did not last long enough to discontinue additional repetitive applications of steroids. Since Meniere's disease is characterized by repeated attacks of vertigo with fluctuating and/or progressive hearing loss unlike other inner ear diseases without recurrence su
Sponsor: Osaka University

Current Primary Outcome: the ratio of patients in vertigo supression and hearing improvement [ Time Frame: post-operative 2-7 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: the ratio of patients in canal improvement [ Time Frame: post-operative 2 years ]

Original Secondary Outcome:

Information By: Osaka University

Dates:
Date Received: July 11, 2007
Date Started: April 1996
Date Completion:
Last Updated: July 23, 2007
Last Verified: July 2007