MénièreNCT04847700
Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
A study testing Surgical treatment in people with Ménière, run by Mansoura University at 1 site in Egypt.
Trial summary
The distinctive symptoms of Meniere's disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ménière
- What is being tested?
- Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral definite Meniere's disease.
Who cannot join
- other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.
- Previous history of chronic otitis media or middle ear surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, ElDakahlia, 35516
Noha A Elkholy, 02-01065488097, nohaaelkholy@gmail.com
About this study
The distinctive symptoms of Meniere's disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and betahistine. When conservative treatment fails, surgical management is attempted. Surgical interventions comprise transtympanic steroids or gentamicin, endolymphatic sac surgery (ES), ventilation tube placement, vestibular neurectomy, and labyrinthectomy. Recently, Loader et al. have presented encouraging results of the effectiveness of tenotomy of the stapedius and tensor tympani muscles (TSTM) in the management of patients with definite MD. Also, satisfactory results were obtained with endoscopic assisted minimally invasive vestibular neurectomy (MIVN). The aim of this study is to compare the clinical outcomes of MD patients who were submitted to either MIVN or TSTM in our department.
- Conditions
- Ménière
- Being tested
- Surgical treatment
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentProcedure or surgery
Endoscopic retrosigmoid minimally invasive vestibular neurectomy
Surgical treatmentProcedure or surgery
Endoscopic tenotomy of middle ear muscles
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive vestibular neurectomy | Active comparator | Not described Receives: Procedure: Surgical treatment |
| Tenotomy of the stapedius and tensor tympani muscles | Active comparator | Not described Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
dizziness handicap inventory (DHI)
contains 25 questions divided into physical, emotional, and functional subgroups. Each question is to be answered using a scale with ''no'' (0 points), ''sometimes'' (2 points), or ''yes'' (4 points). The total score ranges from zero (no incapacity) to 100 (severe incapacity).
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 May 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MénièreStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha A.Elkholy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847700
- Sponsor's protocol ID
- MD.21.02.418.R1
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
- ClinicalTrials.gov ID
- NCT04847700
- Acronym / sponsor ID
- MD.21.02.418.R1
- Conditions
- Ménière
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The distinctive symptoms of Meniere's disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and betahistine. When conservative treatment fails, surgical management is attempted. Surgical interventions comprise transtympanic steroids or gentamicin, endolymphatic sac surgery (ES), ventilation tube placement, vestibular neurectomy, and labyrinthectomy. Recently, Loader et al. have presented encouraging results of the effectiveness of tenotomy of the stapedius and tensor tympani muscles (TSTM) in the management of patients with definite MD. Also, satisfactory results were obtained with endoscopic assisted minimally invasive vestibular neurectomy (MIVN). The aim of this study is to compare the clinical outcomes of MD patients who were submitted to either MIVN or TSTM in our department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive vestibular neurectomy | Active comparator | Procedure: Surgical treatment |
| Tenotomy of the stapedius and tensor tympani muscles | Active comparator | Procedure: Surgical treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral definite Meniere's disease.
Key exclusion criteria (2 listed)
- other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.
- Previous history of chronic otitis media or middle ear surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatmentEndoscopic retrosigmoid minimally invasive vestibular neurectomy | Procedure or surgery | Minimally invasive vestibular neurectomy |
| Surgical treatmentEndoscopic tenotomy of middle ear muscles | Procedure or surgery | Tenotomy of the stapedius and tensor tympani muscles |
Primary outcome
dizziness handicap inventory (DHI)
Time frame: 6 months after surgery
contains 25 questions divided into physical, emotional, and functional subgroups. Each question is to be answered using a scale with ''no'' (0 points), ''sometimes'' (2 points), or ''yes'' (4 points). The total score ranges from zero (no incapacity) to 100 (severe incapacity).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment in people with Ménière, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dizziness handicap inventory (DHI) (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.