Multi-institutional Assessment of the Provox 2 Voice Prosthesis

Abstract

OBJECTIVES: To verify the initial results of a new anterograde replacement method of the second-generation indwelling Provox voice prosthesis, Provox 2 (Atos Medical AB, Hörby, Sweden), and to determine its device life. DESIGN: Nonrandomized, multi-institutional, controlled clinical trial. SETTING: Four academic hospitals and/or comprehensive cancer centers in The Netherlands. PATIENTS: Two hundred thirty-nine consecutive patients who had undergone laryngectomy and were visiting the outpatient clinic for replacement of their voice prosthesis. INTERVENTION: Anterograde replacement of the Provox 2 voice prosthesis. MAIN OUTCOME MEASURES: Evaluation of ease of use by the medical professional and appreciation by the patients, by means of structured questionnaires; comparison of device life between the original Provox and the new Provox 2 voice prosthesis in a subset of patients. RESULTS: Voice prostheses replaced were Provox (n = 188), Groningen (Medin, Groningen, The Netherlands) (n = 47), and Nijdam (Medin) (n = 4). Anterograde replacement of Provox 2 was always possible. The new anterograde method was preferred by the medical professionals in 97.1% of cases and by 93.7% of the patients, who reported significantly reduced discomfort (P<.001). There was no significant difference in device life between Provox and Provox 2 (median, 125.5 and 104 days, respectively). In 57.5% of patients, the Provox 2 device life was shorter and in 42.5% it was longer (sign test, P = .09). CONCLUSIONS: The results of the initial study concerning ease of use for the medical professionals and decreased discomfort for the patients of the new anterograde replacement procedure of the Provox 2 prosthesis were confirmed. The device life of Provox and that of Provox 2 were comparable, despite the alterations needed to optimize the Provox 2 prosthesis for the anterograde procedure.