This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 200 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events.
Specific Aims
Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
English-speaking natal females ≥ 18 years of age
Willing to self-maintain (insert/remove) pessary
Pessary naïve with Stage II-IV POP desiring conservative management with a pessary
Primary indication for use of pessary is treatment of pelvic organ prolapse
Primary indication for pessary use is for management of stress urinary incontinence
Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy)
Short vaginal length (TVL < 8cm) or subjective vaginal narrowing
Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina)
Parallel
Reia System
DeviceReia pessary
Standard of Care Pessary
DeviceGellhorn pessary or ring with/without support without knob pessary
Satisfaction with treatment
The primary outcome will be measured by participant response to the question "How satisfied or unsatisfied are you with your ability to use and manage the pessary provided to you?" with response collected via VAS ranging from "0mm = very unsatisfied" to "100mm = very satisfied" with 50mm = neutral (neither satisfied nor unsatisfied).
Total self-management events
Defined as removing the pessary ≥ one time per 24-hour period over the six-month follow-up period, this outcome will be summed and divided by actual days of follow-up to accommodate minor variation across participants in the exact length of follow-up.
Patient Global Impression of Severity (PGI-S)
A single item questionnaire to assess the patient's impression of disease severity. For purposes of this trial, the investigators have adapted the PGI-I to specifically ask about "prolapse" severity. It will ask participants to "Check the one number that best describes how the participant's prolapse condition is now" on a 4-point Likert scale ranging from (1) normal to (4) severe
Patient Global Impression of Improvement (PGI-I)
A single item questionnaire to assess a patient's impression of change. For purposes of this trial, the investigators have adapted the PGI-I to specifically ask about "prolapse symptoms." It will ask participants to "Check the one number that best describes how the participant's prolapse condition is now, compared with how it was before the participant began this study" on a 7-point Likert scale ranging from (1) very much better to (7) very much worse
Pelvic Floor Distress Inventory-20 (PFDI-20)
A 20-item condition-specific quality-of-life instrument with three scales (6-item Urinary Distress Inventory, 6-item Pelvic Organ Prolapse Distress Inventory, and 8-item Colorectal-Anal Distress Inventory) used to evaluate the impact of pelvic floor disorders on quality of life with a response scale from 0 (not present) to 4 (quite a bit bothersome).
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