Vaginal microflora following the usage of disposable home-use vaginal device, and commercially available ring pessary for pelvic organ prolapse management: A randomized controlled trial

Abstract

Abstract Purpose To investigate whether ProVate™, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as compared with a commercially available ring pessary, in order to assess its microbiological safety. Methods This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (non-inferiority), home-use, cross-over study was conducted at seven sites. Participants were randomized into either group A (using ProVate™ and then a new reusable commercially available ring pessary [control]) or B (using control device and then ProVate™) with a 1:1 ratio. Primary endpoint was based on meeting one of the failure criteria: significant change in Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or Staphylococcus aureus levels compared to the baseline (significant change: Nugent score ≥ 7 or > 1 scale unit increase in S. aureus or Candida morphotype), bothersome vaginal symptoms, or symptoms requiring treatment. Results The study included 58 participants (mean age: 64.5 years, 91.4% post-menopausal). The failure rate was 15.5% for ProVate™ and control groups while using 383 ProVate™ devices over 1,647 days or one control device throughout the study. Two patients had bothersome vaginal complaints and one had vaginal infection in the control group, but no such cases were observed in the ProVate™ group. Conclusion The primary endpoint of possible vaginal microbial changes, bothersome vaginal symptoms, or treatment-requiring vaginal complaints while using ProVate™ was successfully met. Our findings show that the vaginal microflora is comparable when using either ProVate™ or commercially available ring pessary (control) with a relatively low rate of vaginal infections. Trial registration details ClinicalTrials.gov;