Intratympanic steroid injection (ITSI) can be an effective treatment for sudden sensorineural hearing loss or Meniere's disease. Tympanic membrane (TM) perforation after ITSI is a major complication which needs additional treatment. The purpose of this study is to assess the factors associated with TM perforation after ITSI.
We obtained the clinical data of patients who underwent ITSI treatment at the Department of Otolaryngology JR Tokyo General Hospital from April 2013 to March 2021. The data included age, sex, treated side, number of injections, average interval between injections, TM anesthesia with Zentöl solution, which contains phenol, any history of diabetes and any concurrent use of oral or intravenous steroids. We evaluated the association between these variables and TM perforation after ITSI using the Student's t-test, the chi-squared test, univariate logistic regression analysis and multivariate logistic regression analysis. TM perforation was defined as a case in which perforation was observed at least once during outpatient visits.
Records of 205 ears in 190 patients were analyzed. The overall proportion of TM perforation in the early period after ITSI was 12.7% (26 out of 205 ears), which decreased to 9.3% (19 out of 205 ears) and 5.9% (12 out of 205 ears) at the 1- and 3-month follow-ups, respectively. The proportion of TM perforation in the early period after ITSI without TM anesthesia was 3.5% (5 ears out of 145 ears), which decreased to 1.4% (2 ears) or 0% at the 1- or 3- month follow-ups, respectively. The use of tympanic anesthetics which contain phenol was significantly associated with TM perforation in univariate logistic regression analysis (odds ratio: 15.08, 95% confidence interval: 5.34–42.56, p < 0.001) and in multivariate analysis (odds ratio: 20.76, 95% confidence interval: 6.31–68.3, p < 0.001). All TM perforation cases without TM anesthesia healed spontaneously or with paper tympanic closure treatment. TM perforation in 6 ears out of 21 ears with TM anesthesia did not heal during the follow-up.
The overall proportion of TM perforations from the early period after ITSI was 12.7%, 9.3% at the 1-month post-ITSI outpatient follow-up, 5.9% at the 3-month post-ITSI outpatient follow-up. Tympanic anesthesia was significantly associated with TM perforation after ITSI, which indicated that TM anesthesia with solutions containing phenol is not recommended for ITSI.
Abbreviations:ITSI (Intratympanic steroid injection), MD (Meniere’s disease), SDHL (Sudden sensorineural hearing loss)
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- Treatment of Ménière's disease. Middle ear infusion with lidocaine and steroid solution.Auris Nasus Larynx. 1986; 13: 79-89
- Rate of tympanic membrane perforation after intratympanic steroid injection.Am J Otolaryngol - Head Neck Med Surg. 2017; 38: 21-25
- Intratympanic steroid injection for Bell's Palsy: preliminary randomized controlled study.Otol Neurotol. 2014; 35: 1673-1678
- Intratympanic injection of steroid for treatment of tinnitus.Indian J Otolaryngol Head Neck Surg. 2019; 71: 1123-1125
- The efficay of steroids in the treatment of idiopathic sudden hearing loss.Arch Otolaryngol. 1980; 106: 772-776
- Intratympanic steroid injections as a salvage treatment for sudden sensorineural hearing loss: a randomized, double-blind, placebo-controlled study.Otol Neurotol. 2011; 32: 774-779
- Residual perforation risk assessment of intratympanic steroids via tympanostomy tube versus transtympanic injections.Laryngoscope. 2021; 131: E2583-E2591
- Corticosteroid pharmacokinetics in the inner ear fluids: an animal study followed by clinical application.Laryngoscope. 1999; 109: 1-17
- Ventilation tube removal: does treatment affect perforation closure?.Otolaryngol - Head Neck Surg. 2002; 126: 663-668
- Pain assessment of the intratympanic injections: a prospective comparative study.Eur Arch Oto-Rhino-Laryngol. 2012; 269: 2467-2473
- Assessment of complications due to intratympanic injections.World J Otorhinolaryngol Neck Surg. 2016; 2: 13-16
- Intratympanic corticosteroids for sudden idiopathic sensorineural hearing loss.Otol Neurotol. 2005; 26: 878-881
- Systemic side effects of transtympanic steroids.Laryngoscope. 2010; 120: 111
- Study design and statistical analysis: a practical guide for clinicians.Cambridge University Press, 2006
- Complications and prognosis associated with intra-tympanic steroid injection to treat sudden sensorineural hearing impairment.Am J Otolaryngol - Head Neck Med Surg. 2022; 43103221
- Intratympanic steroids as primary initial treatment of idiopathic sudden sensorineural hearing loss: The Hospital Universitario Ramón y Cajal experience and review of the literature.Eur Arch Oto-Rhino-Laryngol. 2013; 270: 2823-2832
- Incidence of tympanic membrane perforation after intratympanic steroid treatment through myringotomy tubes.Ear Nose Throat J. 2011; 90: 21-27
- Clinical efficacy of initial intratympanic steroid treatment on sudden sensorineural hearing loss with diabetes.Otolaryngol Head Neck Surg. 2009; 141: 572-578
- Association between the number of intratympanic steroid injections and hearing recovery in sudden sensorineural hearing loss.Front Neurol. 2021; 12https://doi.org/10.3389/fneur.2021.798569
- Dose effect of intratympanic dexamethasone for idiopathic sudden sensorineural hearing loss: 24 mg/mL is superior to 10 mg/mL.Otol Neurotol. 2015; 36: 1321-1327
- Comparison of 2 and 4 intratympanic steroid injections in the treatment of idiopathic sudden sensorineural hearing loss.Ann Otol Rhinol Laryngol. 2018; 127: 235-240
- Comparison of intratympanic and intravenous dexamethasone treatment on sudden sensorineural hearing loss with diabetes.Otol Neurotol. 2006; 27: 604-608
- Surgical results and factors affecting outcome in patients with fat-graft myringoplasty.Ear, Nose Throat J. 2021; 0: 1-5
- Factors affecting the treatment outcomes of myringoplasty in patients with small tympanic membrane perforations.Eur Arch Oto-Rhino-Laryngol. 2019; 276: 3005-3012
- Tympanic membrane breakdown after intratympanic injection of steroids in irradiated ears.Otol Neurotol. 2007; 28: 499-500
- Tympanic membrane perforation after intratympanic steroid injection: a systematic review and meta-analysis.Otolaryngol - Head Neck Surg. 2022; 166 (United States): 249-259
- Iatrogenic phenol injury causing facial paralysis with tympanic membrane and ossicular necrosis.Otol Neurotol. 2016; 37: 385-387
- Phenol application for tympanic membrane anaesthesia. 2008; 33
- Hydrocortisone delay of tissue repair of experimental tympanic membrane perforations.Ann Otol Rhinol Laryngol. 1990; 99: 647-653
Published online: February 10, 2023
Accepted: January 24, 2023
Received: September 18, 2022
Publication stageIn Press Corrected Proof
The authors have no funding, financial relationships, or conflicts of interest to disclose.
This study was approved by the regional ethical standards committee in the JR Tokyo General Hospital.
© 2023 Japanese Society of Otorhinolaryngology-Head and Neck Surgery, Inc. Published by Elsevier B.V. All rights reserved.