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.


OBJECTIVE
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.
Hilgers
Frans J M
FJ
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, Amsterdam, The Netherlands. f.hilgers@nki.nl
Ackerstaff
Annemieke H
AH
van Rossum
Maya
M
Jacobi
Irene
I
Balm
Alfons J M
AJ
Tan
I Bing
IB
van den Brekel
Michiel W M
MW
D000368:Aged; D000403:Airway Resistance; D055154:Dysphonia / Q000175:diagnosis; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007825:Laryngectomy; D007831:Larynx, Artificial; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D014833:Voice Quality