Document Detail

Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter).
MedLine Citation:
PMID:  20513030     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES/HYPOTHESIS: To assess device life of the new Provox Vega 22.5 and 20 Fr prostheses, to establish whether the optimized airflow characteristics of these devices materialize in better voice characteristics in comparison to Provox2, and to assess the feasibility of voice prosthesis replacement with the new Smart Inserter. STUDY DESIGN: Prospective clinical phase II study. METHODS: Prospective clinical phase II study including two patient cohorts (Provox Vega 22.5 Fr: N = 33; Provox Vega 20 Fr: N = 26). Device-life assessment, subjective data collection with study-specific structured questionnaires, perceptual analysis (Comparative Mean Opinion Score), and objective voice analysis (standard Dutch text, maximum phonation time, and dynamic range). RESULTS: Device life of both prostheses appears comparable to Provox2. Several voice characteristics were better in Vega 22.5, which coincides well with patients' preference. Voicing with Vega 20 appears comparable to Provox2. Use of Smart Inserter showed a short learning curve, and was considered an improvement by the clinicians. CONCLUSIONS: The new Provox Vega 22.5 and 20 Fr prostheses have a device life comparable to Provox2, whereas voicing is better than (with the 22.5 Fr version) or comparable (with the 20 Fr version) to Provox2. The Smart Inserter, after a short learning curve, turns out to be a further improvement of the anterograde replacement of these indwelling devices.
Frans J M Hilgers; Annemieke H Ackerstaff; Irene Jacobi; Alfons J M Balm; I Bing Tan; Michiel W M van den Brekel
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Laryngoscope     Volume:  120     ISSN:  1531-4995     ISO Abbreviation:  Laryngoscope     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-31     Completed Date:  2010-07-15     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8607378     Medline TA:  Laryngoscope     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1135-43     Citation Subset:  IM    
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, University of Amsterdam, Amsterdam, The Netherlands.
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MeSH Terms
Aged, 80 and over
Larynx, Artificial*
Middle Aged
Patient Satisfaction
Prospective Studies
Prosthesis Design
Prosthesis Failure
Prosthesis Implantation / methods*
Voice Disorders / rehabilitation*
Voice Quality

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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