Endolymphatic duct blockage: a randomized controlled trial of a novel surgical technique for Ménière's disease treatment

Objectives: To compare the effectiveness of the endolymphatic duct blockage (EDB) and the endolymphatic sac decompression (ESD) to control Ménière's disease symptoms and to evaluate their effect on hearing level.

Study design: Prospective nonblinded randomized study.

Setting: Tertiary medical center.

Subjects and methods: Fifty-seven patients affected by a refractory Ménière's disease were included out of which 22 underwent an ESD and 35 underwent an EDB. Five periods of follow-up were considered: 0 to 1 week, 1 week to 6 months, 6 to 12 months, 12 to 18 months, and 18 to 24 months. Mean outcome measurements consisted of vertigo control, tinnitus, aural fullness, instability, and hearing level. Hearing level was evaluated using pure-tone average (PTA) and speech discrimination score (SDS).

Results: There was no significant difference between the 2 groups in the number of vertigo spells per months preoperatively (P = .153). Twenty-four months postoperatively, 96.5% of the EDB group had achieved a complete control of vertigo spells against 37.5% of the ESD group with a statistically significant difference (P = .002). There was a better control of tinnitus and aural fullness with EDB (P = .021 and P = .014, respectively). There was no statistically significant difference in hearing level preoperatively (P = .976) and 24 months postoperatively (P = .287) between the 2 groups. Hearing level was preserved in each group with no significant difference between the preoperative and the postoperative levels (P > .05).

Conclusion: EDB is more effective than the traditional ESD in controlling the symptoms of Ménière's disease. It is a novel surgical technique with promising results for a complete treatment of Ménière's disease. There are no significant complications or adverse effect.