Highlights
- •This is the first study to assess the effect of different vaginal pessary replacement intervals for POP on complications and patient satisfaction.
- •A higher complication rate was found in the 6-monthly group compared with the 3-monthly group, but the difference was not statistically significant; patient satisfaction was high and similar in both groups.
- •The paper gives a detailed description of the study protocol, which can be used as a reference for future studies conducted at other centers.
Abstract
Objectives
Limited data are available on the effect of the time interval of vaginal ring pessary
replacement for pelvic organ prolapse (POP). This study investigated the effect of
different replacement intervals on complications and patient satisfaction.
Study design
A double-blinded, randomized controlled trial was conducted in a tertiary urogynecology
center. Women with a vaginal ring pessary for POP (stage I to IV) were randomly allocated
to two groups: 3-monthly or 6-monthly ring pessary replacement. All women were blinded
to the replacement interval. Investigators were blinded during outcome assessment.
Subjects were followed up for 6 months.
Main outcome measures
The primary outcomes were the complication rates and patient satisfaction scores at
6 months. Secondary outcomes were the change in patient-reported symptoms and staging
of POP.
Results
Of 101 women were screened from June 2016 to November 2017, 60 were recruited and
randomly allocated: 30 to the 3-monthly replacement group and 30 to the 6-monthly
replacement group. The overall complication rate in the 6-monthly group was higher
than that in the 3-monthly group at the third visit (9 [30%] vs. 3[10.3%]; OR 3.71;
95%CI 0.89–15.58), but the difference was not statistically significant (p = 0.061).
There were no statistically significant differences between groups in patient satisfaction
scores, other prolapse-related symptoms or staging of POP.
Conclusions
We provide evidence on the effect of replacement interval for a vaginal pessary on
complications and patient satisfaction. A higher complication rate was found in the
6-monthly group than in the 3-monthly group, although the difference was not statistically
significant. Patient satisfaction scores were similar in both groups.
Abbreviations:
POP (pelvic organ prolapse), POP-Q (Pelvic Organ Prolapse-Quantification system), VAS (visual analogue scale), PVC (polyvinyl chlorine), BMI (body mass index)Keywords
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Article info
Publication history
Published online: July 06, 2019
Accepted:
July 1,
2019
Received in revised form:
June 2,
2019
Received:
March 11,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
