Meniere's disease Morbus Meniere
Conditions
Interventions
Dexamethasone (20 mg/ml ) 0,5 * 0,6 ml or gentamicin (40 mg/ ml) 0.5 ml * 0,6
ml.
Patients receive two injections within two weeks.
Sponsors
Gelre Ziekenhuizen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Definite unilateral Ménière's disease according to AAO-HNS criteria: two or more definitive spontaneous episodes of vertigo for at least 20 minutes, AND audiometric confirmation of a sensorineural hearing loss, AND tinnitus (other causes excluded)
 *Not responding to oral medical treatment for at least six months.
 *Age above 18 years at the start of the trial.
 *Willing to adhere to the follow up assessments.
Exclusion criteria
Exclusion criteria: *Ménière's disease in advanced stages (not having vertigo attacks).
 *bilateral Ménière's disease.
 *Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
 *Active additional neuro-otologic disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma).
 *Concurrent ear pathology that may interfere with IT injections (e.g. active middle ear disease).
 *Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
 *History of known adverse and/or allergic reaction to steroids or gentamicin.
 *Women of child bearing age not using contraception, pregnant women or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect a 20% risk difference between the two treatments. A non*inferiority design will be applied with a 10% inferiority margin. If the lower value of the confidence interval of the risk difference is more than 10%, dexamethason will be concluded to be inferior to gentamicin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other endpoints are 12 points decrease in Dizziness Handicap Inventory (DHI) score, Tinnitus Handicap Inventory (THI), Pure Tone Audiometry, Speech Discrimination scores, Level of total hearing loss. | — |
Countries
Netherlands
Outcome results
None listed