PMID- 36401271
OWN - NLM
STAT- MEDLINE
DCOM- 20221122
LR  - 20221127
IS  - 1472-6874 (Electronic)
IS  - 1472-6874 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Nov 18
TI  - Novel, disposable, self-inserted, vaginal device for the non-surgical management 
      of pelvic organ prolapse: efficacy, safety, and quality of life.
PG  - 459
LID - 10.1186/s12905-022-02057-6 [doi]
LID - 459
AB  - BACKGROUND: We evaluated a novel disposable, collapsible, ring-shaped vaginal 
      device that is self-inserted within an applicator and removed with a string. The 
      device was developed to overcome the drawbacks of existing ring pessaries for 
      non-surgical pelvic organ prolapse management (POP). METHODS: The primary 
      objective efficacy endpoint of this prospective, interventional, multicenter, 
      self-controlled, and home-use study was the proportion of subjects with improved 
      staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective 
      efficacy was assessed using the POP symptoms alleviation score. Safety was 
      evaluated by recording the rate and incidence of adverse events (AEs) in a daily 
      diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor 
      Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires. 
      RESULTS: A total of 94 usage cycles were observed in a group of 52 participants 
      (mean age 60.2 +/- 10.5 years, 81.1% postmenopausal) who used the device for 
      3558 days. Of these, 24 participants completed one usage cycle, 14 completed two 
      usage cycles, and 14 completed three usage cycles with 28-45 days of ProVate use 
      in each usage cycle. All patients experienced greater than two POP-Q stage 
      reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of 
      participants. The POP symptom alleviation questionnaire showed significant 
      subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also 
      improved substantially (P < 0.0001 for both). There were 91 nonserious 
      device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal 
      infection, and one case of urinary tract infection. CONCLUSION: The novel device 
      substantially reduces prolapse and provides significant subjective POP symptom 
      relief and QoL improvement, with minimal AEs. The device may enable women to 
      self-manage their prolapse with a small, disposable device that minimizes 
      self-touching and frequent dependency on the clinic. TRIAL REGISTRATION: 
      Clinical. TRIALS: gov , NCT02239133 , posted September 12, 2014 (retrospectively 
      registered).
CI  - (c) 2022. The Author(s).
FAU - Ziv, Elan
AU  - Ziv E
AUID- ORCID: 0000-0002-7187-6048
AD  - ConTIPI Medical Ltd., 2 Alon Hatavor st., 3088900, Caesarea, Israel. 
      eziv@contipi.com.
FAU - Erlich, Tsvia
AU  - Erlich T
AD  - ConTIPI Medical Ltd., 2 Alon Hatavor st., 3088900, Caesarea, Israel.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221118
PL  - England
TA  - BMC Womens Health
JT  - BMC women's health
JID - 101088690
SB  - IM
MH  - Humans
MH  - Female
MH  - Middle Aged
MH  - Aged
MH  - *Quality of Life
MH  - Prospective Studies
MH  - *Pelvic Organ Prolapse/etiology
MH  - Pessaries/adverse effects
MH  - Vagina/surgery
PMC - PMC9673387
OTO - NOTNLM
OT  - Disposable vaginal device
OT  - Non-surgical management
OT  - Pelvic organ prolapse
OT  - Self-inserted device
COIS- EZ has a conflict of interest as he is an employee and shareholder at ConTIPI 
      Medical who developed the studied device. EZ took part in the design of the 
      study, data collection, interpretation of results and in manuscript writing. TS 
      has a conflict of interest as she is a consultant and optionee at ConTIPI Medical 
      who developed the studied device. TS took part in the design of the study, 
      interpretation of results and in manuscript writing.
EDAT- 2022/11/20 06:00
MHDA- 2022/11/23 06:00
PMCR- 2022/11/18
CRDT- 2022/11/19 00:09
PHST- 2022/04/12 00:00 [received]
PHST- 2022/11/03 00:00 [accepted]
PHST- 2022/11/19 00:09 [entrez]
PHST- 2022/11/20 06:00 [pubmed]
PHST- 2022/11/23 06:00 [medline]
PHST- 2022/11/18 00:00 [pmc-release]
AID - 10.1186/s12905-022-02057-6 [pii]
AID - 2057 [pii]
AID - 10.1186/s12905-022-02057-6 [doi]
PST - epublish
SO  - BMC Womens Health. 2022 Nov 18;22(1):459. doi: 10.1186/s12905-022-02057-6.