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).
OBJECTIVE
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.


METHODS
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.
Hilgers
Frans J M
FJ
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, University of Amsterdam, Amsterdam, The Netherlands. f.hilgers@nki.nl
Ackerstaff
Annemieke H
AH
Jacobi
Irene
I
Balm
Alfons J M
AJ
Tan
I Bing
IB
van den Brekel
Michiel W M
MW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007825:Laryngectomy; D007831:Larynx, Artificial; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010699:Phonation; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000379:methods*; D011795:Surveys and Questionnaires; D014832:Voice Disorders / Q000534:rehabilitation*; D014833:Voice Quality