Table 1.

Scientific studies of Rezūm^® System convective radiofrequency water vapor thermal therapy published in peer-reviewed journals

Technology validation and first-in-man studies (1 center, Dominican Republic, histology [n = 7] and gadolinium-enhanced magnetic resonance imaging [n = 15]; Mayo Clinic)

Dixon et al9

Mynderse et al17

Pilot study (3 centers, 3 countries, n = 65 at 1 year, n = 53 at 2 years)

Dixon et al18 1-year data

Dixon et al14 2-year data

Rezūm randomized controlled trial (RCT) study (15 US centers, thermal therapy [n = 136] versus sham procedure [n = 61], with planned 5-year follow-up)

McVary et al,19 1-year data

Roehrborn et al,11 2-year data

Impact on sexual function (RCT subjects to 1 year)

McVary et al22

Crossover study (RCT sham procedure subjects, requalified and crossed to Rezūm thermal therapy, n = 53 at 1 year; planned 5-year follow-up)

Roehrborn et al11