{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["309(2)"],"submitter":["Ziv E"],"funding":["ConTIPI Medical Ltd."],"pubmed_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, to assess its microbiological safety.Methods
This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover 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. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure crite"],"journal":["Archives of gynecology and obstetrics"],"pagination":["571-579"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10808192"],"repository":["biostudies-literature"],"pubmed_title":["Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial."],"pmcid":["PMC10808192"],"pubmed_authors":["Ziv E","Erlich T","Keller N"],"additional_accession":[]},"is_claimable":false,"name":"Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial.","description":"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, to assess its microbiological safety.Methods
This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover 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. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure crite","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Feb","modification":"2026-07-15T10:43:15.212Z","creation":"2025-04-05T21:34:28.241Z"},"accession":"S-EPMC10808192","cross_references":{"pubmed":["37882871"],"doi":["10.1007/s00404-023-07260-w"]}}