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Randomized Controlled Trial
. 2021 Dec 2;11(1):23296.
doi: 10.1038/s41598-021-02848-1.

A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty

Sung-Won Choi  1 , Se-Joon Oh  1 , Yehree Kim  2 , Min Young Kwak  3 , Myung-Whan Suh  4 , Moo Kyun Park  5 , Chi Kyou Lee  6 , Hong Ju Park  2 , Soo-Keun Kong  7
Affiliations
Randomized Controlled Trial

A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty

Sung-Won Choi et al. Sci Rep. .

Abstract

To assess the safety and efficacy of navigation-guided balloon Eustachian tuboplasty (BET) compared to medical management (MM) alone in patients with chronic Eustachian tube dilatory dysfunction (ETD). This is a prospective, multicenter, 1:1 parallel-group, randomized controlled trial (RCT). It aims to assess the efficacy of navigation-guided BET compared to MM alone in patients with chronic ETD. The primary outcome measure was an improvement in the Eustachian tube dysfunction questionnaire (ETDQ)-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided BET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (P = 0.001). More patients experienced tympanogram improvement in the BET group at 6 weeks compared to the control group (36.5% vs. 15.8%) with a positive modified Valsalva maneuver (36.6% vs. 15.8%, P = 0.014). Additionally, air-bone gap change was significantly decreased in the BET group compared to the control group at the 6-week follow-up visit (P = 0.037). This prospective, multicenter, RCT study suggests that navigation-guided BET is a safe and superior treatment option compared to MM alone in patients with chronic ETD.

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Conflict of interest statement

The authors declare no competing interests..

Figures

Figure 1
Figure 1
Participants flow diagram.
Figure 2
Figure 2
The average ETDQ-7 scores preoperatively and at 6 weeks post-procedure.
Figure 3
Figure 3
Tympanogram changes of treatment effects preoperatively and at 6 weeks post-procedure.
Figure 4
Figure 4
Changes in the positive modified Valsalva maneuver preoperatively and at 6 weeks post-procedure.
See this image and copyright information in PMC

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