PROLARYN PLUS clinical study results
PROLARYN PLUS was evaluated in a multicenter, open-label, prospective clinical study.1
STUDY DESIGN: Each patient served as his/her own control. A 5-point rating scale of vocal effort was used: greatly improved, significantly improved, somewhat better, no change, worse.
Patients also rated the amount of effort they felt was required for phonation using a 100-point visual analog scale (the higher number, the more effort upon phonation).1
At 12 months, both patients and physicians reported:
Nearly 70% of patients (n=63) had "greatly improved" or "significantly improved" voice.1
Patient- and physician-observed improvement was confirmed by stroboscopic documentation of vocal fold augmentation and glottal closure.1
STROBOSCOPY: INDICATION OF IMPROVED GLOTTAL CLOSURE (N=59)1
Stroboscopy was used to evaluate vocal fold vibratory and closure features at each patient visit. At baseline the duration of closure in 85% of patients was
classified as always open or predominantly open. In contrast, the 12-month evaluation found that only 20% of treated patients had always open or predominantly open durations of closure.