Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease

Ménière Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847700
• Other study ID #: MD.21.02.418.R1
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• unilateral definite Meniere's disease.

Exclusion Criteria:

• other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.

• Previous history of chronic otitis media or middle ear surgery.

Related Conditions & MeSH terms

• Ménière
• Meniere Disease

Intervention

Procedure:
• Surgical treatment
Endoscopic retrosigmoid minimally invasive vestibular neurectomy
• Surgical treatment
Endoscopic tenotomy of middle ear muscles

Locations

Country	Name	City	State
Egypt	ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University	Mansoura	ElDakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months after surgery