Balloon Eustachian Tuboplasty-A Feasible Double-Blinded Sham Surgery Randomized Clinical Trial Protocol to Study Efficacy.

INTRODUCTION: Balloon Eustachian tuboplasty (BET) is used to treat obstructive Eustachian tube dysfunction (OETD) and recurrent otitis media with effusion (OME). However, there are no indisputable evidence of its efficacy. Here, we present a multicenter, double-blinded, randomized, placebo-controlled trial (MDRCT) design to evaluate the efficacy of BET, and the results of a pilot trial with 3- and 12-months' follow-up. MATERIAL AND METHODS: This was a prospective MDRCT. For a pilot study, OETD (n = 10) and OME (n = 5) patients were recruited and followed. Detailed inclusion and exclusion criteria were used. Participants were randomized at beginning of the operation to active or sham surgery. All procedures were performed under local anesthesia. Controls were performed in double-blinded manner (both patient and physician), at 3 and 12 months after the procedure. RESULTS: Altogether, 20 ears were treated and followed for 12 months, including 14 active BETs and 6 sham surgeries. Both the active and sham surgery were performed under local anesthesia without problems or deviations from the protocol. There were no differences in the preoperative symptoms (ETDQ-7) or objective measures (tympanometry, Valsalva and Toynbee maneuvers, tubomanometry, Eustachian tube score) between active and sham surgery arms. During follow-up, we noticed largely similar reduction in subjective symptoms and improvement in Eustachian tube score both in active and sham surgery arms. CONCLUSIONS: The pilot study demonstrates that our MDRCT protocol is feasible, and that blinded RCTs are dearly needed to objectively measure the efficacy of BET. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:1874-1881, 2024.

Balloon Dilation of the Eustachian Tube in Chronic Eustachian Tube Dysfunction: A Retrospective Study of 107 Patients.

BACKGROUND: Eustachian tube dysfunction affects from 1% to 5% of adults. This study evaluates the effectiveness of balloon dilation of eustachian tube for treating nonselected patients with eustachian tube dysfunction in a long term. METHODS: We evaluated all balloon dilation of eustachian tube operations at Turku University Hospital from 2013 to 2016. The data from 107 patients and 167 ears were collected retrospectively and a questionnaire was sent to these patients regarding their symptoms. RESULTS: An evident reduction of the symptoms was noticed. Aural fullness, otalgia, recurrent acute otitis media, or otitis media with effusion as well as symptoms from changes to ambient pressure and the ability to do the Valsalva maneuver were significantly improved. The mean followup time with the questionnaire was 33 months. Of patients, 80% (36/45) reported long-term reduction of symptoms. CONCLUSIONS: In our study, balloon dilation of eustachian tube seems to have reduced symptoms of eustachian tube dysfunction and the results appear to be long lasting.

Efficacy of Balloon Tuboplasty for Baro-Challenge-Induced Eustachian Tube Dysfunction: A Systematic Review and a Retrospective Cohort Study of 39 Patients.

OBJECTIVE: Baro-challenge-induced Eustachian tube dysfunction (ETD) manifests due to inadequate Eustachian tube (ET) function during rapid ambient pressure changes, although ET function may be normal in normobaric situations. This systematic review and retrospective cohort study aimed to evaluate the effectiveness of balloon Eustachian tuboplasty (BET) for the treatment of baro-challenge-induced ETD. DATA SOURCES: PubMed, the Cochrane Library, Scopus, and Helsinki University Hospital cohort. METHODS: A systematic literature search was conducted in November 2020 and resulted in 174 articles. Eight articles fulfilled the inclusion criteria. Data was available altogether from 74 adult baro-challenge-induced ETD patients. In addition, we retrospectively evaluated 39 BET operations at Helsinki University Hospital from 2011 to 2020. Data from these 39 patients were collected from medical charts, and a questionnaire was sent to the patients. Meta-analysis was used to evaluate subjective symptom improvement, changes in ETD Questionnaire-7 (ETDQ-7) scores, and Valsalva maneuver performance. RESULTS: In the systematic review, the outcome parameters varied between studies. Improvement was reported in subjective symptoms, Valsalva maneuver, ETDQ-7, tubomanometry, and pressure chamber test. Response rate for the Helsinki University Hospital cohort study was 72% (28/39). Mean follow-up time from the BET to the questionnaire was 4 years 8 months (SD 26months). Of those patients 93% (26/28) found the operation beneficial. Meta-analysis including up to 113 patients showed improvement in Valsalva maneuver, ETDQ-7, and improvement in subjective symptoms. Overall improvement in symptoms was noted in 81% of the patients. CONCLUSION: BET seems to be effective in the majority of patients with baro-challenge-induced ETD.

Tubomanometry correlations with patient characteristics and other diagnostic tests of Eustachian tube dysfunction: a cohort study of 432 ears.

OBJECTIVES: Currently, there is no consensus regarding the best protocol for diagnosing Eustachian tube dysfunction (ETD). We aimed to evaluate how patient characteristics affect tubomanometry (TMM) results. If an association between patient characteristics and TMM results exists, this should be considered in TMM interpretation. We also wanted to study if TMM correlates with other diagnostic tools of ETD. METHODS: A retrospective chart review was conducted on all patients with TMM results available from November 2011 to October 2020 at a tertiary referral center, including 432 ears from 219 patients. An association between diagnostic tests and patient characteristics was assessed using regression models. Spearman's rank correlation was used to analyze correlations between diagnostic tests. RESULTS: None of the studied patient characteristics (age, gender, body mass index, smoking, sinonasal disease) was associated with TMM results except for pollen allergy (OR 1.74, 95% CI 1.15-2.63, P = 0.009). TMM results correlated with Valsalva maneuver performance (P < 0.001, ρ = 0.31) and otomicroscopic signs of inadequate middle ear ventilation (P < 0.001, ρ = 0.28). The Eustachian tube dysfunction questionnaire-7 (ETDQ-7) score did not correlate with any diagnostic method. CONCLUSIONS: TMM results are unaffected by patient characteristics other than pollen allergy. Thus, TMM may be used in ETD diagnostics in a wide variety of patients with straightforward interpretation. TMM correlates with other diagnostic tests studied but not with ETDQ-7. ETDQ-7 does not seem to correlate with other diagnostic tests and appears nonspecific in ETD diagnostics.

Tubomanometry Measurement Success Rate in Clinical Practice.

OBJECTIVES: Tubomanometry (TMM) is an objective method for investigating Eustachian tube (ET) function, but difficulties in technique and interpretation may reduce its usability. The objective of our study was to investigate common difficulties with TMM in different ET dysfunction (ETD) patient groups and at different pressures (30, 40, and 50 mbars) when first introducing TMM to otologic practice. Furthermore, we wanted to investigate whether it would be possible to perform TMM at only one pressure and obtain a representative result. METHODS: A retrospective chart review of a 2-year cohort of 114 patients with a history of ETD treated at a tertiary referral center. Primary outcome was the success rate of TMM, secondary the reasons for unsuccessful measurements. Tertiary outcome was the correlation of TMM results at adjacent pressures. RESULTS: TMM success rate was 91%, varying 81 to 94% in different ETD patient groups and 87 to 94% at different pressures. Unsuccessful measurements resulted from air-leaks from the external ear canal, abnormal ear canal pressure curves (R < 0) and at 50 mbar, difficulties in reaching sufficient nasopharyngeal pressure. TMM results were similar in 88% of cases at 30 and 40 mbars and in 86% of cases at 40 and 50 mbars. CONCLUSIONS: TMM success rate seems sufficiently high for clinical diagnostics, and most difficulties may be overcome with proper interpretation during the TMM measurement session, and thus repeating the measurements when necessary. Considering the diagnostic information that would be lost if using only a single, predefined pressure, we suggest using all three pressures.

Isolated cryptorchidism: no evidence for involvement of genes underlying isolated hypogonadotropic hypogonadism.

Mutations in FGFR1, GNRHR, PROK2, PROKR2, TAC3, or TACR3 underlie isolated hypogonadotropic hypogonadism (IHH) with clinically variable phenotypes, and, by causing incomplete intrauterine activation of the hypothalamic-pituitary-gonadal axis, may lead to cryptorchidism. To investigate the role of defects in these genes in the etiology of isolated cryptorchidism, we screened coding exons and exon-intron boundaries of these genes in 54 boys or men from 46 families with a history of cryptorchidism. Control subjects (200) included 120 males. None of the patients carried mutation(s) in FGFR1, PROK2, PROKR2, TAC3 or TACR3. Two of the 46 index subjects with unilateral cryptorchidism were heterozygous carriers of a single GNRHR mutation (Q106R or R262Q), also present in male controls with a similar frequency (3/120; p=0.62). No homozygous or compound heterozygous GNRHR mutations were found. In conclusion, cryptorchidism is not commonly caused by defects in genes involved in IHH.