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.