Timing of Office-Based Pessary Care
Katie Propst,MD, Colleen Mellen,APRN, David M. O’Sullivan,PhD, and Paul K. Tulikangas,MD
OBJECTIVE:To evaluate the influence of pessary visitintervals on development of vaginal epithelial abnormalities.
METHODS: We conducted a randomized, noninferioritytrial of office-based pessary care. Eligible participantswere adult women wearing a ring, Gellhorn, or inconti-nence dish pessary to treat pelvic organ prolapse orincontinence or both. Patients were randomized 1:1 toroutine pessary care (office visits every 12 weeks, “rou-tine” arm) or to extended pessary care (office visits every24 weeks, “extended” arm). The primary study outcomewas rate of vaginal epithelial abnormalities (epithelialbreak or erosion) at the final study visit (48 weeks). Thepredetermined noninferiority margin was 7.5%.
RESULTS: From January 2015 through June 2017, inclusive,448 patients were screened and 130 were randomized, 64to the routine arm and 66 to the extended arm. Baselinecharacteristics of the study arms were similar with theexception of pessary type, with ring pessary more commonin the routine arm and Gellhorn pessary more common inthe extended arm (P5.02). The rate of epithelial abnormal-ities at the final study visit (48 weeks) was 7.4% in theroutine arm and 1.7% in the extended arm (difference,25.7 percentage points; 95% CI27.4 to24), which metthe criterion for noninferiority. Rates of all types of epithe-lial abnormalities did not differ between arms at any time point. Increasing duration of pessary use (P5.003) and his-tory of prior epithelial abnormalities were associated withdevelopment of epithelial abnormalities (P5.01). Otherthan epithelial abnormalities, no adverse events relatedto pessary use occurred in either arm.
CONCLUSION: In women who receive office-basedpessary care and are using a ring, Gellhorn, or inconti-nence dish pessary, routine follow-up every 24 weeks isnoninferior to every 12 weeks based on incidence ofvaginal epithelial abnormalities.CLINICAL TRIAL
REGISTRATION: ClinicalTrials.gov,NCT02371083.(Obstet Gynecol 2020;135:100–5)DOI: 10.1097/AOG.0000000000003580
