Dartmouth-Hitchcock Medical Center
This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the office regularly (2-4 times per year) to manage the pessary. Enrollment in the study will be offered to current patients who have regular office visits to care for their pessary.
This is a prospective interventional trial for patients with at least stage 2 pelvic organ prolapse (POP), who are currently managing their POP with office-based care using a pessary. The study will be conducted at two institutions, Dartmouth-Hitchcock and Pennsylvania State University. The intervention will be to convert willing patients from office-based care to self-care, using a new, collapsible (Reia) pessary in patients. The primary outcome will be a visual analog score (VAS) regarding their current satisfaction with their treatment and management of POP. Secondary outcomes will include…
Inclusion Criteria: * Women currently using office-based pessary management of at least stage 2 POP will be recruited: * English-speaking natal females 18 years or older * Stage II-IV POP desiring continued pessary management. * Primary indication for pessary management is treatment of POP Exclusion Criteria: * Primary indication for pessary is for management of stress urinary incontinence * Vesicovaginal fistula or rectovaginal fistula * Vaginal, rectal or bladder malignancy * Genitourinary infection requiring treatment\* * Ongoing treatment for vaginal infections (e.g., chronic bacterial…
The Reia-System pessary is an FDA-cleared device to manage pelvic organ prolapse which is collapsible and intended to be more easily removed, with less discomfort.
These subjects will continue with the current pessary they are using to manage their prolapse, with office-based care.
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