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. 2020 Jan;135(1):100-105.
doi: 10.1097/AOG.0000000000003580.

Timing of Office-Based Pessary Care: A Randomized Controlled Trial

Katie Propst  1 , Colleen Mellen, David M O'Sullivan, Paul K Tulikangas
Affiliations

Timing of Office-Based Pessary Care: A Randomized Controlled Trial

Katie Propst et al. Obstet Gynecol. 2020 Jan.

Erratum in

Abstract

Objective: To evaluate the influence of pessary visit intervals on development of vaginal epithelial abnormalities.

Methods: We conducted a randomized, noninferiority trial of office-based pessary care. Eligible participants were adult women wearing a ring, Gellhorn, or incontinence dish pessary to treat pelvic organ prolapse or incontinence or both. Patients were randomized 1:1 to routine pessary care (office visits every 12 weeks, "routine" arm) or to extended pessary care (office visits every 24 weeks, "extended" arm). The primary study outcome was rate of vaginal epithelial abnormalities (epithelial break or erosion) at the final study visit (48 weeks). The predetermined noninferiority margin was 7.5%.

Results: From January 2015 through June 2017, inclusive, 448 patients were screened and 130 were randomized, 64 to the routine arm and 66 to the extended arm. Baseline characteristics of the study arms were similar with the exception of pessary type, with ring pessary more common in the routine arm and Gellhorn pessary more common in the extended arm (P=.02). The rate of epithelial abnormalities at the final study visit (48 weeks) was 7.4% in the routine arm and 1.7% in the extended arm (difference, -5.7 percentage points; 95% CI -7.4 to -4), which met the criterion for noninferiority. Rates of all types of epithelial abnormalities did not differ between arms at any time point. Increasing duration of pessary use (P=.003) and history of prior epithelial abnormalities were associated with development of epithelial abnormalities (P=.01). Other than epithelial abnormalities, no adverse events related to pessary use occurred in either arm.

Conclusion: In women who receive office-based pessary care and are using a ring, Gellhorn, or incontinence dish pessary, routine follow-up every 24 weeks is noninferior to every 12 weeks based on incidence of vaginal epithelial abnormalities.

Clinical trial registration: ClinicalTrials.gov, NCT02371083.

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References

    1. Cundiff GW, Weidner AC, Visco AG, Bump RC, Addison WA. A survey of pessary use by members of the American urogynecologic society. Obstet Gynecol 2000;95:931–5.
    1. Ko PC, Lo TS, Tseng LH, Lin YH, Liang CC, Lee SJ. Use of a pessary in treatment of pelvic organ prolapse: quality of life, compliance, and failure at 1-year follow-up. J Minim Invasive Gynecol 2011;18:68–74.
    1. Patel MS, Mellen C, O'Sullivan DM, Lasala CA. Pessary use and impact on quality of life and body image. Female Pelvic Med Reconstr Surg 2011;17:298–301.
    1. Komesu YM, Rogers RG, Rode MA, Craig EC, Gallegos KA, Montoya AR, et al. Pelvic floor symptom changes in pessary users. Am J Obstet Gynecol 2007;197:620–6.
    1. Brazell HD, Patel M, O'Sullivan DM, Mellen C, LaSala CA. The impact of pessary use on bowel symptoms: one-year outcomes. Female Pelvic Med Reconstr 2014;20:95–8.

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