PMID- 37822469
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231031
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 10
DP  - 2023
TI  - A randomized controlled study comparing the objective efficacy and safety of a 
      novel self-inserted disposable vaginal prolapse device and existing ring 
      pessaries.
PG  - 1252612
LID - 10.3389/fmed.2023.1252612 [doi]
LID - 1252612
AB  - INTRODUCTION: ProVate is a novel, disposable, collapsible self-inserted vaginal 
      device for the nonsurgical management of pelvic organ prolapse (POP). We assessed 
      possible vaginal microflora changes and POP reduction using ProVate and a 
      commercially available ring pessary (control). METHODS: We performed post-hoc 
      analysis of data obtained from an interventional, prospective, multicenter, 
      open-label, randomized, controlled, statistically powered (noninferiority), 
      home-use, cross-over study conducted at seven sites. Safety and performance data 
      collected for both devices were analyzed to compare objective POP reduction 
      (employing the Pelvic Organ Prolapse Quantification System [POP-Q]), safety 
      (assessed by the incidence of adverse events [AEs]), and the rates of certain 
      AEs. RESULTS: Eighty-five women with symptomatic POP were screened; 71 were 
      randomized, and 58 completed the study per protocol. Forty-nine (90.7%) ProVate 
      users experienced complete prolapse reduction (stage 0), 3 (5.6%) experienced 
      reductions to POP-Q stage 1, and 2 (3.7%%) experienced reductions to stage 2. 
      Collectively, 52/54 (96.3%) ProVate users experienced prolapse reduction to stage 
      0 or 1. In all, 47/57 (82.5%) control users experienced complete prolapse 
      reduction, while 5 (8.8%), 4 (7.0%), and 1 (1.8%) experienced reductions to stage 
      1, 2, and stage 3, respectively. Collectively, 52/57 (91.2%) control users 
      experienced reductions to either stage 0 or 1. In 53/54 (98.1%) ProVate and 55/57 
      (96.5%) control users, there was at least 1 POP-Q stage prolapse reduction, and 
      in 32 (91.4%) ProVate and 31 (83.8%) control users who had stage >/=3 prolapse, 
      there were at least three POP-Q stage reductions. In total, 26/71 (36.6%) ProVate 
      and 22/64 (34.4%) control users in the safety population experienced AEs. The 
      incidence of device-related AEs was 17/71 (23.9%) for ProVate and 13/64 (20.3%) 
      for the control. Most AEs were minor, mild, and anticipated. CONCLUSION: Our 
      analysis demonstrated that ProVate and the control are highly effective in 
      reducing POP, and both are associated with comparably low numbers of AEs. 
      However, ProVate has the advantage of being more user-friendly, suitable for home 
      use, and expected to allow women with POP to practice better and easier 
      self-care.
CI  - Copyright (c) 2023 Ziv and Erlich.
FAU - Ziv, Elan
AU  - Ziv E
AD  - ConTIPI Medical Ltd., Caesarea, Israel.
FAU - Erlich, Tsvia
AU  - Erlich T
AD  - ConTIPI Medical Ltd., Caesarea, Israel.
LA  - eng
PT  - Journal Article
DEP - 20230926
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC10562599
OTO - NOTNLM
OT  - disposable vaginal device
OT  - non-surgical management
OT  - pelvic organ prolapse
OT  - ring pessaries
OT  - self-inserted device
COIS- EZ has a conflict of interest as he is an employee and shareholder of ConTIPI 
      Medical, the company that developed the studied device. EZ took part in the 
      design of the study, data collection, interpretation of the results, and 
      manuscript writing. TE has a conflict of interest as she is a consultant and 
      optionee at ConTIPI Medical, the company that developed the studied device. TE 
      took part in the design of the study, interpretation of results, and manuscript 
      writing.
EDAT- 2023/10/12 06:43
MHDA- 2023/10/12 06:44
PMCR- 2023/09/26
CRDT- 2023/10/12 04:03
PHST- 2023/07/04 00:00 [received]
PHST- 2023/09/11 00:00 [accepted]
PHST- 2023/10/12 06:44 [medline]
PHST- 2023/10/12 06:43 [pubmed]
PHST- 2023/10/12 04:03 [entrez]
PHST- 2023/09/26 00:00 [pmc-release]
AID - 10.3389/fmed.2023.1252612 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2023 Sep 26;10:1252612. doi: 10.3389/fmed.2023.1252612. 
      eCollection 2023.