Meniere's Disease
Conditions
Interventions
Group 2:intratympanic gentamicin Injection
Sponsors
Shandong Provincial ENT Hospital Affiliated to Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with unilateral Ménière's disease (2015 barany) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear; 2. Pure tone audiometry shows that the average threshold of three frequencies of 500, 1k, 2k Hz >= 60dB HL, and (or) speech recognition rate is <= 50%.
Exclusion criteria
Exclusion criteria: 1. Tumors of the inner auditory canal or cerebellopontine angle; 2. Older than 70 years at the start of the trial; 3. Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up; 4. Concurrent ear pathology that may interfere with treatment (e.g. active middle ear disease); 5. Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity); 6. History of known adverse/allergic reaction to gentamicin or anaesthetic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vergito attack controlling rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| hearing loss rate;speech recognition rate;caloric test UW value;abnormal cVEMP rate;vHIT gain;ear fullness;tinnitus;Functional level scale;cerebrospinal fluid leakage rate;facial paralysis rate;meningeal infection rate;tympanic membrane perforation; | — |
Countries
China
Contacts
Public ContactWang Haibo
Shandong Provincial ENT Hospital Affiliated to Shandong University
Outcome results
None listed