Efficacy of balloon Eustachian tuboplasty

Not Applicable

Completed

• Conditions: Persistent secretory otitis media, severe symptoms of ETD or baro-challenged ETD; Ear, Nose and Throat; Nonsuppurative otitis media, unspecified; other disorders of Eustachian tube

• Registration Number: ISRCTN50406162
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-23
• Study Completion: 2022-05-31
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

All patients in this study suffer from dilatory Eustachian tube dysfunction and are deemed suitable for BET. Possible indications are:
1. Persistent secretory otitis media
2. Severe symptoms of ETD
3. Baro-challenged ETD

Exclusion Criteria

1. The occurrence of cleft palate in any form
2. Current ventilating grommet
3. Tympanic membrane perforation
4. Adhesive otitis
5. Cholesteatoma
6. Cystic fibrosis
7. Immotile cilia syndrome
8. Untreated nasal polyposis
9. Samter's triade
10. Untreated gastroesophageal reflux disease
11. Other mechanical obstruction in nasopharynx

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured at baseline, 3 months and 1 year:<br> 1. Valsalva maneuver based on physicians descriptive findings<br> 2. Otomicroscopy based on physicians descriptive findings<br> 3. Tympanometry results classified as A, B and C type outcomes<br> 4. Tubomanometry results based on the Eustachian tube opening and opening latency index<br> 5. Need for grommets<br>

Secondary Outcome Measures

Name	Time	Method
Quality of life measured with disease specific questionnaire ETDQ7 at baseline, 3 months and 1 year