Development and Clinical Evaluation of a Second-generation Voice Prosthesis (Provox®2), Designed for Anterograde and Retrograde Insertion

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Abstract
Prosthetic voice restoration has considerably improved the results of vocal rehabilitation after total laryngectomy, and is presently the method of choice for many health-care providers treating laryngectomized patients. The Provox® voice prosthesis, developed in the Netherlands Cancer Institute, is an indwelling device that has been applied in recent years with regular success. Its retrograde replacement method, using a disposable guide wire, assures reliable, atraumatic positioning of the prosthesis in the tracheoesophageal fistula. However, the method sometimes may be uncomfortable for the patient; therefore an adapted prosthesis and new replacement equipment were developed, which enable bidirectional insertion, i.e. not only in the traditional retrograde manner through the pharynx, but especially in an anterograde manner through the stoma. This second-generation voice prosthesis (Provox®2) was studied in a prospective clinical trial in 44 patients (33 experienced patients, seven first-time replacements and four primary insertions). The study demonstrated that the anterograde insertion with the Provox®2 system was applicable in all patients, making the voice prosthesis even easier to handle than with the traditional retrograde method. A stenosis of the pharyngoesophageal segment no longer interfered with the replacement. In addition, the patients judged the new method as being favourable, reporting significantly less discomfort during the replacement procedure (paired Student's r-test: P -< 0.0001). Furthermore, the adapted voice prosthesis could be removed from the tracheoesophageal fistula without excessive force (mean 7.9 N, range 6.0-14.0 N), more easily than the original Provox® (mean 20.9 N, range 5.5-25.0 N). It can be concluded that this second-generation indwelling voice prosthesis (Provox®2) seems to be a further improvement in the application of this voice rehabilitation system, not only simplifying the replacement procedure, but also diminishing the discomfort for the patient.