Provox Voice Prosthesis Research Articles

Tracheoesophageal Voice Rehabilitation after Total laryngectomy: Primary Versus Secondary Tracheoesophageal Puncture

Background: Voice prosthesis is the current standard for post laryngectomy rehabilitation. Several clinical factors can affect the functional outcomes of voice prosthesis. Various complications are recorded with voice prosthesis. Objective: This study aimed to compare the results of primary and secondary provox insertion in patients with advanced laryngeal carcinoma undergoing total laryngectomy. Patients and Methods: Randomized-controlled clinical study included 24 patients with provox voice prosthesis rehabilitation 12 had primary tracheoesophageal puncture and 12 had secondary tracheoesophageal puncture. All patients were evaluated for successful voice restoration and complications rates. Results: Short-term success rate was 92% in the primary group and 83% in the secondary group. Long-term success rate was 83% in the primary group and 75% in the secondary group. Success rates were higher in the primary group but without statistically significant difference. Complications rate in the primary group was 58.3% and in the secondary group 66.6%. Complications rate was higher in the secondary group but without statistically significant difference. Conclusion: Provox voice prosthesis provides consistent and good voice results, which improve with time. Primary provox insertion had better success rates and fewer complications. Periprosthetic leak is the most common complication.

A questionnaire to assess olfactory rehabilitation for laryngectomized patients (Provox voice prosthesis users) in Japan

ObjectiveWe used a questionnaire to investigate olfactory function and the present state of olfactory rehabilitation for laryngectomized patients in Japan. MethodsThis study was conducted using a questionnaire survey. We mailed questionnaires to 190 members of a Japanese laryngectomized patient group (the nonprofit organization YOUSAY-KAI). The survey queried the following items: (1) basic information (age, sex, alaryngeal speech method, etc.); (2) questions about olfactory rehabilitation, such as the individual’s experience of olfactory rehabilitation, the number of days from laryngectomy to the start of olfactory rehabilitation, and the location of rehabilitation (i.e., hospital or patient association); (3) free comments; and (4) the self-administered Odor Questionnaire (SAOQ). ResultsWe received 121/190 questionnaires by the submission deadline. Of these, 105 questionnaires were valid. All 105 responders used the Provox voice prosthesis as the alaryngeal speech method. Only 4.7% (5/105) of the patients received olfactory rehabilitation in hospitals. Many comments in the free comment column included demands for olfactory rehabilitation such as “I want to know where we can have olfactory rehabilitation” and “I want to have rehabilitation if olfaction recovers.” The SAOQ score was significantly higher in the rehabilitation group (mean, 42.5%) compared to the nonrehabilitation group (mean, 22.1%) (p<0.05). There was no correlation between the SAOQ score and the number of days from laryngectomy to the start of rehabilitation (r=0.08, p=0.76)． ConclusionPatient demand for olfactory rehabilitation is strong, but this therapy is not widely offered to laryngectomized patients in Japan. Notably, the SAOQ scores showed that olfactory rehabilitation may have an effect, even if it is initiated after laryngectomy. We believe that when patients choose voice prosthesis for speech, their olfaction deteriorates unless they undergo olfactory rehabilitation separately from speech rehabilitation. It is therefore necessary to administer olfactory rehabilitation for laryngectomized patients who have never received olfactory rehabilitation, as well as for patients scheduled to undergo laryngectomy.

''Ses Protezim Nerede?'' Nadir Bir Aspirasyon Olgusu

Tracheo-esophageal speech prosthesis are devices used for voice rehabilitation of patients with total laryngectomy. This device is placed between the trachea posterior wall and the esophagus frontal wall by a surgical procedure. Although there are various complications related to the use of the device, aspiration of the device is a rare situation. A patient undergoing total laryngectomy 14 years ago, when woken up one morning he noticed that the voice prosthesis was not in place and he applied to the otorhinolaryngology clinic. The patient had no respiratory complaints. The patient was not aware that he had aspirated his prosthesis. Hyperlucency at the right lung was detected on chest film. Diagnostic flexible fiberoptic bronchoscopy showed Provox voice prosthesis at the main carina. The device was removed with forceps without complication. In conclusion, Even without respiratory complaints, the possibility of aspiration with lost voice prosthesis in patients should always be considered.

Factors influencing the longevity and replacement frequency of Provox voice prostheses.

This study aimed to assess the factors that influence the longevity and replacement frequency of Provox voice prostheses following their placement. The medical records of 27 patients who received Provox voice prostheses after total laryngectomy and attended follow-up regularly between 1998 and 2012 were retrospectively reviewed. The success rate of the Provox voice prostheses (i.e. whether speech was achieved), quality of speech achieved, number and type of complications encountered, frequency of prostheses replacement and reasons for prostheses replacements were evaluated. All 27 patients were men and their mean age was 63.0 (range 43-78) years. The mean follow-up period was 60.3 (range 1-168) months. Fluent and understandable speech was achieved in 85.0% of the patients. The mean duration before prosthesis replacement had to be performed was 17.1 (range 1-36) months. The most frequent complication was fluid leakage through the prosthesis. There was a strong positive correlation of 77.1% between the longevity of prostheses and postoperative follow-up duration (r = 0.771; p < 0.01). The voice prosthesis is a tool that can be delivered in a practical fashion and replaced easily with no serious complications. It is a means by which speech can be restored, with a high success rate, after total laryngectomy. In the present study, we found that postoperative follow-up duration was the most important factor influencing the longevity of the Provox voice prosthesis.

Results of Voice Rehabilitation With Provox Prosthesis and Factors Affecting the Voice Quality

Voice prosthesis is the standard of care for postlaryngectomy voice rehabilitation. We aimed to assess functional outcomes of Provox voice prosthesis, to study the impact of several clinical factors (timing of Provox insertion, type of pharyngeal closure, requirement of reconstruction, performance of myotomy, and radiotherapy) on the functional outcomes, and to record the complications associated with Provox voice prosthesis. Prospective nonrandomized cross-sectional observational study. Thirty patients with postlaryngectomy speech rehabilitation with Provox prosthesis were studied. After the procedure, the patients were evaluated by a speech-language pathologist and assessed at immediate postoperative period and 6-month and 1-year interval using the parameters of functional outcomes GRBAS scale, maximal phonatory duration (MPD), and words per breath (WPB). SPSS Version 19 was used for statistical analysis. All patients had average good voice at the end of 1year after Provox insertion with voice quality results improving with time. Number of patients having MPD more than 7 was 21, 29, and 30 at 0months, 6months, and 1year, respectively. At the end of 1year, 11 patients had WPB score between 15 and 19. Seven patients had complications: periprosthetic leak (4), central leak (1), hypertonic segment (1), and stricture of the neopharynx (1). Primary Provox insertion, nonrequirement of postoperative radiation, cricopharyngeal myotomy, and primary and vertical closure of neopharynx had a better influence on the outcome; however, the results were not statistically significant. Provox voice prosthesis provides consistent and good voice results, which improve with time. Periprosthetic leak is the most common complication.

Provox 2 use for voice restoration after total laryngectomy

This study aims to determine the problems of patients applied provox 2 voice prosthesis for speech rehabilitation with their prosthesis and our treatment modalities to increase the quality of life of these patients. A total of 210 patients (180 males, 30 females; mean age 58±11.9 years; range 37 to 83 years) who underwent total laryngectomy, applied and changed provox 2 voice prosthesis for voice restoration were included in the study. For speech restoration of the patients with a primary (intraoperative) and secondary (postoperative) tracheoesophageal fistula was opened. In the 15th postoperative day, provox 2 voice prosthesis was placed to approximately 0.5 cm inferior and midline fistula line of the tracheostoma. The patients underwent speech exercises. The mean change time of prosthesis was 7.5 months (range 1 to 48 months). Fungal colonization was detected in 141 patients (66%) who had voice prostheses. Granulation tissue developed around the voice prosthesis in 30 patients (14%), three patients (1%) swallowed their voice prosthesis, tracheoesophageal fistula width remained permanently in two patients (1%), and these patients were abandoned to use their voice prosthesis. Mediastinitis occurred in one patient (1%). Due to several reasons such as success of high speech despite of complications and being easy to fight with these complications, provox voice prosthesis is an effective method to use for voice restoration.

Microbial colonization of Provox voice prosthesis in the Indian scenario.

Tracheoesophageal speech using the voice prosthesis is considered to be the "gold standard" with success rates as high as 90%. Despite significant developments, majority eventually develop dysfunction due to microbial deterioration. We did a pilot study of 58 laryngectomy patients who developed prosthesis dysfunction. A total of 58 laryngectomy patients who had their dysfunctional prosthesis removed were included in this study. Dysfunctional prostheses were removed and examined. Esophageal and tracheal flanges were examined separately. After obtaining pure fungal and bacterial cultures, the yeast strains were identified. Bacteria were identified with the light microscope and gram staining. We analyzed prosthesis lifespan and probable factors affecting it. Central leak was found in 43% cases while in 57% peri-prosthetic leakage was the most common reason for prosthesis replacement. Microbial analysis revealed a combination of yeast and bacteria in approximately 55% culture samples. Out of these, almost 90% had the presence of single yeast species with bacteria. Pure fungal culture was identified in rest of the 45% cultures while none detected pure bacterial forms. Candida tropicalis was the solitary yeast in 81% while Candida albicans was seen in 10% as the solitary yeast. Bacterial isolates revealed Klebsiella pneumonia in 19%, Escherichia coli in 8% while Staphylococcus aureus was grown in 1% cultures. The consumption of curd (P = 0.036, 95% confidence intervals [CI]: 2.292-64.285) to have a significant correlation of the mean prosthesis lifespan. Consumption of curd (P = 0.001, 95% CI: 0.564-2.008) and history of prior radiotherapy (P = 0.015, 95% CI: 0.104-0.909) had a significant bearing on the Provox prosthesis lifespan. Candida is the most common organism grown on voice prosthesis in Indian scenario. Consumption of curd and history of prior radiotherapy significantly affect Provox prosthesis lifespan.

Microbial colonization of tracheoesophageal voice prostheses (Provox2) following total laryngectomy

The purpose of this study was to determine the presence of individual microorganisms and the most frequent microbial combinations in the biofilm of the indwelling Provox2 voice prosthesis in situ. Furthermore, we wanted to evaluate the possible influence of biofilm composition on the mean and median lifetime of these voice prostheses. Over a 5-year period, implantation of a Provox2 voice prosthesis was performed in 85 patients, or 90% of the overall number of patients who underwent total laryngectomy. In total 100 implanted voice prostheses, at least one of every patient, were microbiologically processed immediately after being replaced. Out of the total of 292 isolates, 67% were bacteria and the remaining 33% were yeasts. The most frequently found yeast species on voice prostheses biofilms was C. albicans, followed by C. krusei and C. tropicalis. The most frequently isolated bacteria included Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, and Streptococcus agalactiae. Simultaneous presence of bacteria and fungi was established in 83% of the processed voice prostheses; in 16% of samples the biofilm contained only one or more bacterial species. The mean time of implantation was 238 days and the median lifetime of the device was 180 days. Dividing the prostheses in four groups according to the composition of biofilm revealed that the device lifetimes varied significantly between groups. The longest lifetime of voice prostheses was associated with the presence of single fungal isolate in combination with bacteria. There is a significant correlation between biofilm composition and the device life time.

喉頭摘出後のＰｒｏｖｏｘ２による音声獲得と長期経過観察

From January 2000 to December 2008, we conducted voice rehabilitation using the Provox2 voice prosthesis total-laryngectomy subjects. Of these, 36 attained restoration of 90.0%. Mean maximum phonation time (MPT) was 14.5s, ranging from MPT was not influenced by age, radiotherapy use, primary tumor site, or reconstructive surgery use. Voice prosthesis replacement averaged 25 weeks (5.8 months), ranging from 9 to 74 weeks. Complications occurred in 16 caces (40.0%), mainly granulation tissue formation and prosthesis-site infection, also aspiration pneumonia, prosthesis-site salivary leakage, inability to replace the prosthesis, tracheomalacia, bodies in the trachea. Management rather than medical problems included cost, frequent hospital visits, and lack of motivation to use a prosthesis. The Provox2 voice prosthesis speech provides a higher rate of speech restoration, longer phonatory better intelligibility. Management problems, however, require that we work to understand subjects' living environments and family situations better for evaluating Provox2 voice prosthesis indication more effectively.

Total voice prosthesis incarceration in the trachaeo-oesophageal mucosa. Report of a new complication when using phonatory prostheses

We report the cases of three patients seen at the Otolaryngology Department after presenting a laryngeal carcinoma that required total laryngectomy, followed by tracheo-oesophageal puncture and Provox voice prosthesis positioning. In all cases, the growth of granulomatous tissue totally incarcerated the prosthesis in the tracheo-oesophageal mucosa. In two of the cases, the prosthesis could be extracted by oesophagoscopy and a new prosthesis positioned in the same surgery. In the third case, an external approach was performed using a peristomal incision to extract the prosthesis. A new tracheo-oesophageal puncture was then performed 3 months after the extraction.

Incarceración total de prótesis fonatoria en la mucosa traqueoesofágica. Informe de una nueva complicación con el uso de prótesis fonatorias

We report the cases of three patients seen at the Otolaryngology Department after presenting a laryngeal carcinoma that required total laryngectomy, followed by trachaeo-oesophageal puncture and Provox voice prosthesis positioning. In all cases the growth of granulomatous tissue totally incarcerated the prosthesis in the trachaeo-oesophageal mucosa. In two of the cases the prosthesis could be extracted by oesophagoscopy and a new prosthesis was positioned in the same surgery. In the other case an external approach was performed using a peristomal wound to extract the prosthesis. In this case a new trachaeo-oesophageal puncture was performed 3 months after the extraction.

Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega)

Conclusions: Provox Vega prostheses demonstrate good short-term feasibility, and their optimized airflow-resistance design offers laryngectomy patients indwelling voice prostheses with more choices in outer diameters without sacrificing (too) much in voice quality. Objectives: Technological progress enables improvement of in vitro airflow characteristics of voice prostheses and design of voice prostheses with smaller outer diameters. This could potentially improve voice quality in users of Provox2, and avoid diminished voice quality in users of prostheses with smaller outer diameters. Methods: This was a prospective clinical phase I/feasibility study of three newly designed indwelling voice prostheses (Provox Vega 22.5 (Provox2 successor), 20, and 17Fr). Assessments consisted of patients' self-reported voice and speech, perceptual evaluation, acoustic analysis, maximum phonation time, loudness, speech rate, pull-out force and adaptation of the tracheoesophageal (TE) puncture to smaller diameter voice prostheses. Vega 22.5 was assessed in 15 patients (all Provox ActiValve users, observation period 3 weeks), and 16 patients with Vega 20/17 (2 weeks each). Results: No voice prostheses problems were encountered. Half of the patients with Vega 22.5 preferred that for its better voice quality. Voice and speech were considered equal to Provox2 for Vega 20, but slightly less for Vega 17. Most TE punctures adapted well to the smaller diameter voice prostheses.

Voice rehabilitation with Provox2™ voice prosthesis following total laryngectomy for laryngeal and hypopharyngeal carcinoma

Objective To analyze the effectiveness of the Provox2 voice prosthesis for voice rehabilitation following total laryngectomy. Methods From September 2000 to December 2004, the Provox2 voice prosthesis was used for voice rehabilitation in 32 patients following total laryngectomy. The quality of speech with the Provox2 voice prosthesis was analyzed using the HRS rating scale, the maximum phonation time (MPT), incidence of complications and the in situ lifetime. The rate of speech restoration was further analyzed in 129 patients with total laryngectomy from 1996 to 2004. Result Twenty-nine of 32 patients were able to restore speech using the Provox2 voice prosthesis, a speech restoration rate of 90.6%. The maximum phonation time (MPT) was measured in 18 patients using the Provox2 voice prosthesis. The mean MPT was 15.1 s, with a range of 8–28 s. MPT was not influenced by age, concurrent radiotherapy treatment, the location of the primary tumor or use of reconstructive surgery. The average lifetime of the Provox2 in patients with laryngeal carcinoma (12 patients) and hypopharyngeal carcinoma (17 patients) was 27.2 and 16.6 weeks, respectively, which was significantly different ( P = 0.024, non-parametric Mann–Whitney's U-test). The rate of speech restoration by the use of esophageal speech, and insertion of an artificial larynx was 62.7% for laryngeal carcinoma (59 cases) and 38.6% for hypopharyngeal carcinoma (70 cases), which was also significantly different ( P < 0.01, chi-square test). Conclusion Provox2 voice prosthesis speech was very useful due to the higher rate of speech restoration, longer phonatory time, and better intelligibility. It was also thought that voice prosthesis speech was useful in conjunction with esophageal speech and an artificial larynx depending on the patient's condition or wishes.

Postlaryngectomy Voice Restoration Using a Voice Prosthesis: A Single Institution's Ten-Year Experience

We describe the speech rehabilitation outcome of patients treated with total laryngectomy or total laryngopharyngectomy and insertion of Provox voice prostheses (Atos Medical AB, Hörby, Sweden) at the Helsinki University Central Hospital. We performed a retrospective chart review of 95 patients (88 men and 7 women; mean age, 63.5 years) who underwent insertion of a voice prosthesis in the period 1992 to 2002. Eighty-one percent (77/95) of the patients underwent a primary prosthesis insertion at the time of laryngectomy. A head and neck surgeon, a laryngologist, and a speech therapist rated the long-term tracheoesophageal speech of 78% (74/95) of the patients as good or average. The main causes for replacement of the device were obstruction, leakage or inadequate size of the prosthesis, and granulation or leakage around the fistula. According to our 10-year experience, use of the Provox prosthesis is an effective method of postlaryngectomy voice rehabilitation, and it continues to be our preferred method of voice restoration in the majority of cases.

Long-term results of provox voice prosthesis for voice rehabilitation after total laryngectomy “A seven years experience”

The increasing use of voice prostheses has improved the prospects of voice rehabilitation in laryngectomised patients. Provox voice prosthesis is a low resistance, indwelling silicon voice prosthesis, which is recently widely used in many centers.The purpose of this study is to present the long-term results obtained using provox voice prostheses. Patient's problems voice, quality and complications are discussed.During the last 7 years, 100 laryngectomised patients have been using 375 Provox voice prostheses. There were 92 (92%) men and 8 (8%) women. Age ranged from 31 to 69 years (mean 54.3 years). Mean lifetime of the prosthesis was 14.6 months. The main reason for valve replacement was leakage through the prosthesis (73.4%) followed by leakage around the prosthesis (10.4%). Spontaneous dislocation occurred in 5 prostheses (12%), all were Provox 2. The voice was rated good in 85 patients (85%), fair in 10 patients (10%) and 5 patients (5%) had poor voice in which three of them had no prosthetic voice.In conclusion, long-term results of provox voice prosthesis for speech rehabilitation following total laryngectomy are favorable with low complication rate and a long device lifetime.

Quality of Life in Laryngectomees after Prosthetic Voice Restoration

Background: In oncology, the paradigms for evaluating the results of treatment have shifted over the last few years. Preserving or restoring the quality of life has become an equally important aim of medical treatment as complete excision of the tumor and the duration of patient survival. Following laryngectomy, adequate speech restoration is one major aim of therapy. Different replacement strategies of voice production such as tracheoesophageal speech, esophageal speech, or electrolarynx are in use. The reporting department is able to restore speech in more than 90% of the patients; the majority uses tracheoesophageal speech with Provox^® voice prosthesis. The purpose of the study was to assess the quality of life in laryngectomees after successful voice restoration with Provox voice prosthesis. Patients and Methods: In a cross-sectional study 25 laryngectomees whose voice had been restored by tracheoesophageal puncture and Provox voice prosthesis were examined for quality of life. The Short Form 36-Item Health Survey (SF-36) was used as an international and highly standardized test. Results: In comparison with a standardized healthy German male population, the patients showed more limited physical functioning as well as more restricted physical and emotional role functions. However, the laryngectomees did not attain lower scores for bodily pain. According to the patients’ statements their social functioning, vitality, and their mental health were not excessively limited; mental health and vitality were even better than in patients with heart or renal failure and hepatitis C. General health was fairly similar to a standard population. Conclusions: After laryngectomy, patients have deficits in physical and emotional well-being. Concepts of therapy should increasingly focus on how to deal with physical limitations and the patient’s apperception. Successfully restored voice minimizes social, mental and vitality limitations. The SF-36 is a suitable instrument for quality of life assessment in order to define disease-dependent and individual limitations of quality of life in laryngectomees and should lead to individual interventions.

A new and simple modification of the prosthetic voice restoration technique.

Several problems have been observed when performing the classic endoscopic technique for voice restoration following laryngectomy. An easy and safe method is described for the insertion of a Provox voice prosthesis using a Yankauer tonsil suction tube and an antrum trocar with an irrigation cannula.

Coping strategies in laryngectomy patients

Over the last few years, paradigms for judging the results of treatment of tumor patients have shifted. In addition to characteristics such as the complete excision of the tumor and the duration of patient survival, restoring the quality of life has become an equally important aim. There is still a lack of systematic (and sufficient) research on coping strategies as a means of dealing with malignant tumors of the head and neck. In a cross-sectional study, 25 laryngectomees, whose voices had been successfully restored with a Provox voice prosthesis,were examined for their coping strategies and the effects of the illness on their lives. The standardized Trier Scales of Coping Strategies and a custom-made questionnaire, which helped to structure the anamnesis of disease specific functional restrictions and the state of rehabilitation, were used as the means of inquiry. A high percentage of patients were content despite objective and subjective restrictions. Voice replacement was mainly experienced as unproblematic,with psychosocial restraints more commonly being felt in connection with pain and difficulties ingesting food. A correlation between the patients' evaluation of physical,psychological and social experiences and the coping strategies applied could not be verified. The way laryngectomees deal with their illness does not differ from the strategies of patients suffering from malignant or chronic diseases of other organ systems. The Trier Scales of Coping Strategies is a suitable means for determining the coping strategies of laryngectomees who have been successfully rehabilitated with the help of voice prostheses. The patients examined here did not apply different coping strategies from groups of patients with other severe illnesses. Obviously, the limitations on communication do not constitute a determining factor in coping with the disease. This finding is useful when planning psychological and social rehabilitation, e.g. by psychosomatic interventions.

Voice rehabilitation after laryngectomy with the Provox voice prosthesis in South Africa.

A study was undertaken to determine whether the Provox voice prosthesis provides good voice rehabilitation following a total laryngectomy in the urban, suburban and rural populations served by a tertiary referral hospital in South Africa. Between 1995 and 1999, a cohort of 128 patients at Tygerberg Hospital was rehabilitated with the Provox voice prosthesis after laryngectomy. In 104 patients primary placement of the prosthesis was done at the time of the laryngectomy. Mean device life and adverse events were determined. Voice quality was assessed subjectively in 104 patients and objectively in 26 patients. The mean device life was 303 days and adverse events occurred in 16 patients. Subjectively, 77 of 104 patients had a good voice, and objectively 22 of 26 patients had good voice intelligibility. The Provox voice prosthesis provides good voice rehabilitation following total laryngectomy, with minimal complications, in the population served by Tygerberg Hospital.

Provox voice prosthesis — The Indian experience

Following Total Laryngectomy, Tracheo-oesophageal speech prosthesis offers the most reliable form of voice rehabilitation. Of the various prostheses currently available. The Provox voice prosthesis developed by the Netherlands Cancer Institute has been the most popular due to its superior design and in-dwelling nature.At the Apollo Cancer Hospital, Hyderabad, 17 patients underwent speech rehabilitation with the Provox voice prosthesis between February 1999 and July 2000. Speech rehabilitation was successful in all patients with the majority (82%) developing Good-Excellent speech. Two patients required replacement and one patient discontinued use of the prosthesis. There were no complications in any of the other patients.