Electrophysiological activity of the pharyngoesophageal transition of total laryngectomees.

OBJECTIVES/HYPOTHESIS: To determine the association of the electrophysiological activity of the pharyngoesophageal transition with tracheoesophageal speech proficiency in total laryngectomees. STUDY DESIGN: An observational (nonexperimental) study of the correlation type with a descriptive approach. METHODS: Thirty-four individuals (26 males), average age 62.5 years, total laryngectomees rehabilitated with the use of a tracheoesophageal prosthesis, were assessed for tracheoesophageal speech proficiency using an adapted protocol and classified as good, moderate, or poor speakers. Next they were submitted to electromyography of the muscles of the pharyngoesophageal transition with a needle electrode. The area to be examined was located by videofluoroscopy. Electromyographic analysis was characterized as normal, neurogenic injury (moderate to severe, severe, severe to total), myopathic injury, or inconclusive. The Fisher exact test was used to determine the association between the speech proficiency variables and electromyography. RESULTS: in the final rating of tracheoesophageal speech proficiency, most laryngectomees were categorized as moderate (n = 24) and a few as good (n = 3). Electromyography revealed neurogenic injury in all laryngectomees, which was severe in most cases (n = 20), followed by severe to total (n = 10), and moderate to severe injury (n = 4). There was no significant association between he electromyographic analyses of neurogenic injuries and tracheoesophageal speech proficiency. CONCLUSIONS: Whether or not the musculature of the pharyngoesophageal transition of tracheoesophageal speakers had a preserved motor unit, did not prevent voice acquisition and was not associated with tracheoesophageal speech proficiency. However, further studies are needed in this area. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:1369-1375, 2017.

Novel esophageal speech therapy method in total laryngectomized patients: biofeedback by intraesophageal impedance.

The loss of the best communication port after total laryngectomy surgery makes speech rehabilitation an important goal. Our aim was to improve the quality of esophageal speech (ES) using online esophageal multichannel intra-luminal impedance (MII) as a new biofeedback method. Twenty-six total laryngectomized patients were included. Before ES therapy, an esophageal motility test was carried out. MII catheters were placed in all subjects who were then randomized into two groups. Group 1 included 13 cases, who were retrained according to the classical method. Group 2 included 13 cases, who were retrained according to the simplified animation of air movements within the esophagus and upper stomach resulting from the modifications of intra-esophageal air kinetics gained by MII. The level of speech proficiency was evaluated relative to pretraining levels using perceptual scales in the third and sixth months. Acoustic voice was analyzed. The number of syllables read per minute and the intelligibility of monosyllabic and dissyllabic words were calculated. In this study, MII was used for the first time in alaryngeal speech rehabilitation as a biofeedback method; an overall sufficient speech level was achieved by 68.4% at the end of therapy, whereas attendance was 90%. A statistically significant improvement was found in both groups in terms of ES level compared with the pretraining period although there was no significant difference between groups. Although we did not observe the expected difference between groups suggested by our hypothesis, MII may be used as an objective tool to show patients how to swallow and regurgitate air during training, and may thus expedite ES therapy both for the speech therapist and the patient in the future.

Evaluation of prophylaxis treatment of Candida in alaryngeal patients with tracheoesophageal voice prostheses.

OBJECTIVES/HYPOTHESIS: The objective of this study was to evaluate the effectiveness of nystatin and Biotène(®) mouthwash Oral Rinse for controlling Candida in total laryngectomy (TL) patients with a tracheosophageal voice prosthesis (TEP) because Biotène(®) mouthwash Oral Rinse is a less costly alternative to nystatin and requires less adherence time. STUDY DESIGN: Randomized, unblinded, crossover trial. METHODS: Twenty-one TL patients were randomized to receive nystatin followed by Biotène(®) mouthwash Oral Rinse, or the reverse order, after a basic oral-care phase (i.e., brushing teeth, cleaning dentures). A Provox(®) 2, 22.5 French TEP, which is an indwelling silicone voice prosthesis, was placed at the beginning of each phase. Patients were provided with oral care instructions at randomization and medication-specific instructions with each treatment's initiation. TEPs were processed and evaluated for Candida growth as colony-forming units (CFUs). Wilcoxon signed-rank tests were used for comparisons between treatments. RESULTS: Fifteen patients were available for comparisons of Candida counts (6 received nystatin; 9 received Biotène(®) mouthwash first). Overall, the median log10 (CFUs) remained high regardless of treatment (no medication: 8.9; nystatin: 8.7; Biotène(®) mouthwash: 8.4). However, the median counts for both nystatin and Biotène(®) mouthwash Oral Rinse were lower than those for no medication (difference [Δ]:-0.9 and -0.3, respectively), although only nystatin was significantly lower (P = 0.02). There was no significant difference between the two treatments (P = 0.22). Overall, median medication-adherence was high (97%), and Biotène(®) mouthwash adherence was significantly higher than that of nystatin (Δ: 7.6%; P = 0.03). CONCLUSION: Nystatin and Biotène(®) mouthwash Oral Rinse had similar CFU levels, with nystatin showing a significant improvement over usual oral care. Biotène(®) mouthwash is a less costly alternative to nystatin, with a less complex treatment protocol that might make it preferable to patients and clinicians. LEVEL OF EVIDENCE: 1b

Management of voice prosthesis leakage with Blom-Singer large esophage and tracheal flange voice prostheses.

INTRODUCTION: Voice rehabilitation after total laryngectomy is a major socio-economic challenge. Voice rehabilitation can be achieved by voice prostheses, which provide rapid patient satisfaction. Enlarged tracheo-oesophageal puncture is a frequent complication and can be difficult to manage. MATERIAL AND METHOD: A prospective study was conducted from November 2010 to October 2011 on 28 Blom-Singer large oesophageal and tracheal flange voice prostheses placed in 18 patients with enlarged tracheo-oesophageal puncture causing leakage around the voice prosthesis. RESULT: Leakage around the voice prosthesis resolved in all patients with a mean prosthesis lifespan of 95 days. The patients considered voice quality to be similar to that obtained with the initial voice prosthesis. CONCLUSION: The Blom-Singer large oesophageal and tracheal flange voice prosthesis is a useful solution for the management of periprosthetic leakage ensuring similar voice quality and an identical lifespan to that of other voice prostheses.

A prospective, randomized comparative study of patient perceptions and preferences of two types of indwelling voice prostheses.

BACKGROUND: Technical and device life issues are frequently the focus of post-laryngectomy rehabilitation studies examining indwelling voice prostheses. Patient perceptions and preferences are considered less often. AIMS: To determine patient perceptions of two indwelling voice prostheses across parameters relating to device use and maintenance and to determine what factors contribute to patient preferences. METHODS & PROCEDURES: In a randomized, cross-over study, 31 laryngectomy patients completed a 3-week trial of both the new indwelling Provox Vega and a comparator device, the Blom-Singer Classic Indwelling. Patient perceptions of the insertion process, cleaning and care, and voicing were explored after each trial. At the end, overall preference and factors influencing device preference were examined. OUTCOME & RESULTS: At the conclusion of the crossover trial, a significantly higher proportion of patients felt voice effort, overall voicing, bloating, and ease and effectiveness of cleaning were superior for the Provox Vega. No preference was noted for insertion processes. Overall device preference was influenced by improved voicing followed by cleaning and care. CONCLUSIONS & IMPLICATIONS: Patients do not perceive all indwelling devices as equal and should have the opportunity to trial different devices to find the best device for their needs.

[An influence of some factors on the logopedic rehabilitation of patients after total laryngectomy]. / Wplyw wybranych czynników na rehabilitacje logopedyczna chorych po calkowitym usunieciu krtani.

INTRODUCTION: The operation of total laryngectomy deprives patients of the ability of voiced communication, causes isolation and loneliness. The loss of voice and speech leads to a predominant cripplehood, disturbs verbal communication in the social and family circle. The best ways of voiced communication of the patients after laryngectomy are an esophageal speech and the speech using voice prosthesis. AIM: The aim of the study is to estimate the voice and speech rehabilitation of the patients after total laryngectomy. MATERIAL AND METHODS: The study comprised 30 patients who in the years 2007-2009 underwent an operation of laryngectomy at the Department of the Surgery of the Head and Neck and the Laryngological Oncology in the Greater Poland Cancer Center in Poznan. In this group 9 patients used voiced speech after grafting the voice prosthesis, 15 patients (12 men and 3 women) underwent a classical rehabilitation of the esophageal speech, 6 patients (4 men and 2 women) used an electronic voice prothesis. The most important factors which influenced on mastering an esophageal speech were: pressure inside the esophagus, appearing a reverberation, time of training at home, length of time of logopedic rehabilitation, age and education. RESULTS: Necessary time to master a speech in the group of 9 patients with voice prothesis was 4-5 days. Length of time of the classical speech rehabilitation lasted from 3 to 8 months. 3 persons (20%) mastered a very good degree of esophageal speech, 7 patients a good degree (46.67%) and 2 patients (13.33%) - a sufficient degree of esophageal speech despite of low pressure inside the esophagus and appearing a reverberation quickly. 3 patients (20%) used an oral and guttural pseudo-whisper, a voiced reverberation was not obtained during the whole time of logopedic rehabilitation. CONCLUSIONS: The surgical voice rehabilitation, in spite of the possibility of complications, enjoys a great popularity among patients. The classical rehabilitation of the esophageal speech was more difficult for the tasted group of patients but mastering a speech to a very good and good degree lets communicate naturally.

Perceptual characteristics of tracheoesophageal speech production using the new indwelling Provox Vega voice prosthesis: a randomized controlled crossover trial.

BACKGROUND: The objective of this study was to determine if the design enhancements incorporated into the new Provox Vega Indwelling Voice prostheses result in any positive benefits in vivo. METHODS: Using a randomized, crossover study design, 31 participants using tracheoesophageal speech postlaryngectomy completed a 3-week trial of the Provox Vega and a comparator device. Main outcome measures included patient perceptions of vocal effort and quality using each device, and perceptual judgments of voice quality produced. RESULTS: The majority of patients (72%) indicated the Provox Vega gave them overall better voice quality and 52% felt they required less effort to phonate. Voice samples produced with the Provox Vega were also perceived by listeners to be significantly (p < .05) less strained, easier to understand, produced with less effort, and the better speech sample overall. CONCLUSION: Results support that the aerodynamic improvements incorporated in the design of the new Provox Vega facilitate enhanced voice and speech qualities.

Voice-related quality of life (V-RQOL) outcomes in laryngectomees.

BACKGROUND: Laryngeal cancer has a significant impact on patients. This study compared the Voice-Related Quality of Life (V-RQOL) outcomes specific to 3 different postlaryngectomy voice rehabilitation methods. METHODS: We conducted a retrospective review of 75 patients with laryngectomy from our V-RQOL questionnaire database. RESULTS: The database included 18 electrolaryngeal speech (ELS), 15 esophageal speech (ES), and 42 tracheoesophageal speech (TES) patients. Pairwise comparisons of V-RQOL outcomes showed that TES was perceived to be better than ELS (p < .001). ES was perceived as better than ELS, but this was driven by a difference in the total and social-emotional V-RQOL scores (p < .05). There was no difference between TES and ES groups. Only ELS showed a positive correlation with time after surgery and older age. CONCLUSIONS: Patients using TES had similar V-RQOL outcomes compared to ES and both performed significantly better than ELS. For ELS, the total V-RQOL score was better with longer time after surgery and older age.

Tracheostomaplasty: A surgical method for improving retention of an intraluminal stoma button for hands-free tracheoesophageal speech.

BACKGROUND: We describe a minimally invasive surgical technique, tracheostomaplasty, to overcome anatomical deformities of the stoma that preclude successful retention of a stoma button for hands free tracheoesophageal (TE) speech. METHODS: We conducted a retrospective analysis of 21 patients who underwent tracheostomaplasty after laryngectomy to accommodate an intraluminal valve attachment for hands-free TE speech. RESULTS: Sixteen men and 5 women (median age, 65 years; median follow-up, 27.7 months) underwent tracheostomaplasty; 6 patients developed a mild cellulitis that required therapy and 5 patients required a minor revision surgery. At last follow-up, 15 (71%) patients successfully achieved hands-free TE speech using an intraluminal stoma button. Three patients only retained the intraluminal device to facilitate digital occlusion. Tracheostomaplasty failed in 3 patients because of granulation tissue formation or stomal stenosis. CONCLUSIONS: Tracheostomaplasty is a successful technique to improve intraluminal retention of a stoma button for hands-free TE speech in laryngectomy patients.

Surgical voice restoration after total laryngectomy: an overview.

Total laryngectomy is potentially a debilitative surgery resulting in compromise of some of the most basic functions of life including speech and swallowing. This may have a profound adverse effect on the patient's physical, functional, and emotional health, and may result in a decreased quality of life (QOL). Until the 1980s, total laryngectomy was regarded as a dreadful, but often, life-saving procedure for which there was little alternative, and was used as a last resort. At that time survival at any cost in terms of QOL was paramount and many laryngectomies were forced into an isolated life as a mute and dysphasic recluse. Most attempts at voice restoration produced inconsistent results and often techniques were laborious, expensive, and ineffective, particularly when carried out as a salvage procedure after failed radiotherapy. Progress in voice rehabilitation, following total laryngectomy, over the last 30 years, has made an enormous difference in the whole concept of the management of laryngeal cancers. Currently there are several options available for these patients, namely, esophageal speech, artificial larynx, and tracheoesophageal speech. The choice of speech rehabilitation varies from patient to patient, but tracheoesophageal voice has become the preferred method. This article provides a brief account of surgical voice restoration after total laryngectomy. Special emphasis has been given to the surgical technique, special considerations, complications, and the prevention / treatment of tracheoesophageal voice restoration.

Further experience with modification of an intraluminal button for hands-free tracheoesophageal speech after laryngectomy.

Tracheoesophageal (TE) speech using a voice prosthesis and hands-free speaking valve with an intraluminal attachment is the gold standard for voice restoration after total laryngectomy. Modification of a standard self-retaining silicone cannula or laryngectomy button often aids in the attachment of a speaking valve within the tracheal lumen for hands-free TE speech production. An increased number of laryngectomized individuals are able to achieve hands-free TE speech when the standard length, flange, and diameter of a silicone button is customized to accommodate individual tracheostomal contours. A technique is presented for modification of a standard silicone laryngectomy button to facilitate hands-free TE speech after total laryngectomy.

Tracheostoma humidifier: influence on secretion and voice of patients with total laryngectomy.

BACKGROUND: total laryngectomy has several consequences such as loss of the laryngeal voice and alterations in the respiratory system. AIM: to evaluate the influence of a tracheostoma humidifier (heat moisture exchanger - HME) on the control of lung secretion and esophageal and tracheoesophageal vocal quality in patients with total laryngectomy. METHOD: nine male individuals, aged between 46 to 67 years, submitted to total laryngectomy. The patients answered a protocol containing subjective questions related to lung secretion in three different moments: T1 (pre-use assessment of the HME), T2 (pre-use assessment of the HME six weeks after the first assessment) and T3 (assessment six weeks after the use of the HME). Voice samples were recorded during these 3 different assessments and were evaluated by three speech-language pathologists, in a blind study format, according to a perceptual auditory vocal analysis protocol. The non-parametric test of Wilcoxon was used to compare results of both protocols. RESULTS: no significant differences were observed for tracheoesophageal and esophageal vocal quality in the three different moments of assessment: T1 (pre-use assessment of the HME), T2 (pre-use assessment of the HME six weeks after the first assessment) and T3 (assessment six weeks after the use of the HME). On the other hand, there were significant differences, after the period of the HME use, regarding occurrence of cough and forced expectoration during the day time. CONCLUSION: The use of the HME during the period of six weeks reduced cough and expectoration of patients with total laryngectomy. However, the use of the humidifier did not have any influence on the tracheoesophageal and esophageal vocal quality of these patients.

Umidificador de traqueostoma: influência na secreção e voz de laringectomizados / Tracheostoma humidifier: influence on secretion and voice of patients with total laryngectomy

TEMA: a laringectomia total acarreta sequelas como a perda da voz laríngea e alteração no sistema respiratório. OBJETIVOS: avaliar a influência do uso do umidificador de traqueostoma (heat moisture exchanger - HME) no controle da secreção pulmonar e na qualidade vocal esofágica e traqueoesofágica de pacientes submetidos à laringectomia total. MÉTODO: nove pacientes do sexo masculino, com idades entre 46 a 67 anos, submetidos à laringectomia total. Os pacientes responderam a um protocolo sobre questões subjetivas relacionadas à secreção pulmonar em três momentos, sendo T1 (avaliação pré-uso do HME), T2 (avaliação pré-uso do HME após seis semanas da primeira avaliação) e T3 (avaliação após seis semanas do uso do HME). Conjuntamente foram feitas gravações das vozes dos pacientes nos mesmos três momentos citados acima. As vozes foram avaliadas por três fonoaudiólogas, em estudo cego, de acordo com um protocolo de avaliação perceptivo-auditiva da voz. Para comparar os resultados obtidos em ambos os protocolos aplicados foram utilizados teste não-paramétrico e Wilcoxon. RESULTADOS: não foi observada nenhuma diferença estatisticamente significativa dos parâmetros de qualidade vocal esofágica ou traqueoesofágica entre os tempos T1 (avaliação pré-uso do HME) e T2 (avaliação pré-uso do HME pós seis semanas) e T3 (avaliação após seis semanas do uso do HME). Verificaram-se diferenças estatisticamente significativas para as variáveis de quantidade de tosse e expectoração forçada, durante o dia, após o período de uso do HME. CONCLUSÃO: O uso do HME durante seis semanas diminuiu a tosse e a expectoração em pacientes laringectomizados totais, porém não apresentou influência na qualidade vocal esofágica ou traqueoesofágica.

BACKGROUND: total laryngectomy has several consequences such as loss of the laryngeal voice and alterations in the respiratory system. AIM: to evaluate the influence of a traqcheostoma humidifier (heat moisture exchanger - HME) on the control of lung secretion and esophageal and traqueoesophageal vocal quality in patients with total laryngectomy. METHOD: nine male individuals, aged between 46 to 67 years, submitted to total laryngectomy. The patients answered a protocol containing subjective questions related to lung secretion in three different moments: T1 (pre-use assessment of the HME), T2 (pre-use assessment of the HME six weeks after the first assessment) and T3 (assessment six weeks after the use of the HME). Voice samples were recorded during these 3 different assessments and were evaluated by three speech-language pathologists, in a blind study format, according to a perceptual auditory vocal analysis protocol. The non-parametric test of Wilcoxon was used to compare results of both protocols. RESULTS: no significant differences were observed for traqueoesophageal and esophageal vocal quality in the three different moments of assessment: T1 (pre-use assessment of the HME), T2 (pre-use assessment of the HME six weeks after the first assessment) and T3 (assessment six weeks after the use of the HME). On the other hand, there were significant differences, after the period of the HME use, regarding occurrence of cough and forced expectoration during the day time. CONCLUSION: The use of the HME during the period of six weeks reduced cough and expectoration of patients with total laryngectomy. However, the use of the humidifier did not have any influence on the traqueoesophageal and esophageal vocal quality of these patients.

[Results of rehabilitation of voice and speeches after implantation of valve vocal prosthesis at ill after total removal of larynx]. / Wyniki rehabilitacji glosu i mowy po wszczepieniu wentylowych protez glosowych u chorych po calkowitym usunieciu krtani.

Ill applying with extensive infiltration of new-growth within of larynx will demand radical therapeutic procedure, which is operation completely removals of organ. Aim of work was estimation of voice and speeches ill with vocal fistula in comparison with oesophageal voice and speech and with physiological. With research one embraced 81 men in age 42-75 of years. Group I--32 ill with cancer of larynx, to which executed total laryngectomy and placed the voice prosthesis Provox 2. Group II--30 ill after operation total removals of larynx, whiches used oesophageal speech. The control group III--19 persons with physiological voice. Research one began from subjective estimation of replacement voices. Then one executed measurements maximum phonation time of vowel "a". To objective estimation of voice one used polish programme "IRIS". One compared: maximum intensities of voices for colloquial speech, F0, Jitter, Shimmer and NHR. In subjective estimation voice of the patients with voice prostheses was greater freedom of production and voice of the patients with voice prostheses appeared to be more loud in relation to oesophageal voice. Greatest statistical essential differences one obtained between maximum phonation times of vowels "a" where clearly is visible, that values obtained for voices of the patients with voice prostheses are to nearer values for physiological voices. Obtained averages values of acoustic analysis: F0, Jitter, Shimmer and NHR did not show statistical of essential differences between voices supplementary, though parameters of voice of the patients with voice prostheses one was to nearer parameters of physiological voice. Characterization perceptive and acoustic speech of the patients with voice prostheses in comparison with oesophageal speech is to nearer characterization of physiological speech. Lack of satisfactory effects of rehabilitation of oesophageal speech, should be effective secondary implantation vocal prosthesis.

Development and evaluation of a novel tracheostoma button and fixation system (Provox LaryButton and LaryClip adhesive) to facilitate hands-free tracheoesophageal speech.

CONCLUSION: This newly developed tracheostoma button and fixation system was appreciated by the majority of the patients in this study and led to an increased use of automatic speaking valves (ASVs). OBJECTIVE: Development and prospective clinical evaluation of a new tracheostoma button and fixation system to enhance hands-free speech in laryngectomized patients. PATIENTS AND METHODS: The Provox LaryButton and LaryClip adhesive system were prospectively evaluated in 11 patients: 10 male, 1 female; mean age 60.5 years, range 46-80 years; median follow-up since laryngectomy 4.9 years, range 9 months to 21 years. A study-specific questionnaire was used and the observation period was 3 weeks. RESULTS: Eight patients were compliant, three dropped out of the study. The LaryClip adhesive system was tried by seven of these compliant patients, and ultimately used by six. At the start of the study two patients used an ASV on a daily basis, three alternated between an ASV and regular, manually operated heat and moisture exchangers (HME), three only used a HME. At the end of the study, three used the ASV daily, five alternated between ASV and HME. Seven patients indicated that they would continue using the new system, six with clips and one with the button only.

Evaluación espectral cualitativa de la voz esofágica / Qualitative spectral evaluation of oesophagic voice

Objetivos: Determinar la capacidad que ofrece la espectrografía acústica como herramienta diagnóstica en la caracterización y monitorización de la voz esofágica. Material y métodos: Se estudiaron 33 sujetos laringectomizados (todos varones) que participaron en un protocolo acústico cualitativo (espectrografía de la voz, vocal /a/ y frase), acústico cuantitativo (tiempo de fonación, frecuencia fundamental, intensidad máxima de presión sonora, speech rate) y análisis perceptual (aceptabilidad psicoacústica de la voz). Resultados: Se ha encontrado una relación estadísticamente significativa entre los trazados espectrográficos clasificados según los criterios de Yanagihara (modificados), la aceptabilidad psicoacústica de la voz y los parámetros acústicos cuantitativos. Conclusiones: La espectrografía acústica es un método fiable y sencillo, aplicable al estudio de la voz esofágica con el propósito de monitorizar la evolución en el aprendizaje de la voz esofágica, en virtud de mejorar la rehabilitación de los laringectomizados

OBJECTIVES: The aim of the study is to determine the accuracy of acoustic spectrography as an outstanding tool in the characterization and monitoring of esophageal voice. MATERIAL AND METHODS: Our subjects were comprised of 33 laryngectomized patients (all male) that underwent qualitative acoustic (spectrography of vowel /a/ and a sentence), quantitative acoustic (phonation time, fundamental frequency, maximun intensity sound level, speech rate) and perceptual protocol. RESULTS: There is a significant statistical relationship among Yanagihara-like spectrographic chart classification, psycho-acoustical perception and quantitative acoustic parameters. CONCLUSION: We consider that acoustic spectrography is an easy, effective method for studying esophageal voice, seeking for improving oral communication skills and rehabilitation in the laryngectomee population

Voice and speech after laryngectomy.

The aim of the investigation is to compare voice and speech quality in alaryngeal patients using esophageal speech (ESOP, eight subjects), electroacoustical speech aid (EACA, six subjects) and tracheoesophageal voice prosthesis (TEVP, three subjects). The subjects reading a short story were recorded in the sound-proof booth and the speech samples were acoustically analysed. Speech sound production was judged by 15 students of phonetics. The following variables were considered: (1) voice quality: fo, jitter, shimmer and harmonic-to-noise ratio, (2) speech sound production: number of recognized VCV syllables, and (3) temporal organization of speech: duration of the phonetic block, number of syllables in the phonetic block, rate of speech, rate of articulation and number of syllables in the longest phonetic block. The results showed that nearly normal air-stream source (lungs) in speech production of speakers with tracheoesophageal prosthesis significantly contributed to the speech timing and speech intelligibility of the alaryngeal speakers.

Effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox silicone tracheoesophageal voice prosthesis.

CONCLUSION: Daily application of a buccal bioadhesive slow-release nystatin tablet (100,000 IU per tablet) significantly increased the voice prosthesis lifetime in laryngectomized patients compared to conventional local cleaning of the prosthesis with an antimicrobial agent on a brush. OBJECTIVE: To investigate the effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox tracheoesophageal voice prosthesis in post-laryngectomy patients. MATERIAL AND METHODS: A buccal bioadhesive tablet, based on a spray-dried Amioca/Carbopol 974P mixture containing 10% (w/w) Carbopol 974P, was loaded with 100,000 IU of nystatin. Patients were included in the study when replacement of their voice prosthesis was required and were divided into three groups. Conventional daily local cleaning of the voice prosthesis by means of an oral nystatin suspension on a brush (Group 1; n = 7) was compared with application of one nystatin buccal bioadhesive tablet per day, after breakfast, on the gingiva above the upper canine (Group 2; n = 7). The control group (n = 5) used no antimicrobial agents. The lifetime of the prosthesis was followed and expressed in days. RESULTS: The lifetime of the voice prosthesis was significantly increased in Group 2 compared to Group 1 (p < 0.05; paired t-test), indicating that sustained release of nystatin in the oral cavity, by means of erosion of the tablet over a period of approximately = 8 h, is more effective at preventing microbial colonization of the prosthesis than local cleaning.