EDB for Ménière's disease

The effectiveness of endolymphatic duct blockage versus endolymphatic sac decompression in patients with intractable Ménière’s disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20715

Enrollment

Registered

2020-11-13

Start date

2021-01-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ménière's disease

Interventions

Participants from both study groups will undergo mastoidectomy with identification of the ED. In the EDB group, the ED will be clipped and in the decompression group, it will not be clipped. All parti

Eligibility

Inclusion criteria

Inclusion criteria: - Definite unilateral MD according to diagnostic criteria of the Bárány Society (Lopez-Escamez, 2016) - More than 3 patient reported attacks in the 6 months prior to inclusion and at least 1 attack in the 2 months prior to inclusion - Age = 18 years at the start of the trial - Non responding to a sufficient extent to conservative medical treatment including at least two sessions of at least one intra-tympanic injection (IT) each with corticosteroids (dexamethasone, methylprednisolone, triamcinolonacetonide) - Dutch health care insurance

Exclusion criteria

Exclusion criteria: - Severe disability (e.g. neurological, orthopedic, cardiovascular) according to the investigator, pregnancy or serious concurrent illness that might interfere with surgery or follow-up. - Active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine (VM), recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma, congenital disorders, enlarged vestibular aquaduct (EVA)-like or genetic disorders (like DFNA9), cervicogenic dizziness), based on the complete clinical record. - Previous ear surgery for MD (IT injection is not an exclusion criterion) - Language difficulties - Active otitis media (with or without effusion) - Unable or unwilling to use DizzyQuest App - Unable to undergo MRI (such as gadolinium allergy, claustrophobia, implanted non-MRI compatible device of material, BMI) - Deafness of the contralateral ear

Design outcomes

Primary

Measure	Time frame
Proportion of patients free of vertigo attack at 12 months follow up	—

Secondary

Measure	Time frame
Secondary outcomes are defined as minimally clinically significant differences in - cumulative incidence of vertigo bouts - hearing - use of escape medication - co-interventions - complications of surgery - questionnaire outcomes (FLS, DHI, THI, SF-36, EQ-5D VAS, iPCQ, iMCQ) - CEA - BIA - endolymphatic hydrops on MRI - physiotherapeutical outcomes	—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)