A prospective randomized multicenter clinical trial of the Provox2 and Groningen Ultra Low Resistance voice prostheses in the rehabilitation of post-laryngectomy patients: a lifetime and preference study

To prospectively study patients' preference for and the lifetime of the Groningen Ultra Low Resistance (GULR) and Provox2 tracheo-esophageal shunt prosthesis (TESP, plural TESPs) in post-laryngectomy patients. Eighty post-laryngectomy patients were included in 4 oncological centers in the Netherlands. We used a repeated measures design study with 4 randomized groups in a partial cross-over design using 3 consecutive TESPs (3 intervals) in different orders. (Group 1: GULR-GULR-GULR; Group 2: GULR-GULR-Provox2; Group 3: Provox2-Provox2-GULR; and Group 4: Provox2- Provox2-Provox2). Replacement dates and reasons for replacement were monitored with questionnaires as were patients' preferences for GULR or Provox2. A great variability of lifetime within and between groups was seen. Mean lifetimes found (all groups and intervals added) were 106.2 and 102.7 days, and median lifetimes were 76 and 65 days for GULR and Provox2, respectively. Lifetime showed no significant differences between groups, intervals, and TESP types. Many patients dropped out due to reasons having to do with GULR-characteristics (n=21). The main dropout reason was "high phonating resistance (HPR)" (57.1%). Only 10 patients preferred GULR. A significantly larger number of patients (n=39, 79.6%) preferred Provox2 either by choice or by dropping out due to GULR-characteristics (P<0.001). The main replacement reasons were "leakage though TESP" (GULR 59.1%, Provox2 52.1%) and HPR (GULR 15.9%, Provox2 12.7%). No significant differences in lifetime between GULR and Provox2 were found. The patients' preference for Provox2 was significant (P<0.001). Patients' preference was a more important outcome measurement in TESP effectiveness than device lifetime.