An interventional study of Reia System and Standard of Care Pessary in Pelvic Organ Prolapse and Prolapse, sponsored by Medstar Health Research Institute. Active, not recruiting at 9 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
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.
509 studies on the registry are indexed under Pelvic Organ Prolapse; 81 are open to participants now.
This study's planned enrollment of 218 is above the median of 80 across 330 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse
Participants receiving the commercially available RS will be fit with one of three available pessary sizes and will receive an applicator corresponding to their pessary size.
Device: Reia System
Participants receiving SPC will be fit with a Gellhorn pessary or ring with/without support without knob pessary per standard clinical protocol.
Device: Standard of Care Pessary
Reia pessary
Gellhorn 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).
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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).
Time frame: 6 months
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
A 7-item condition-specific quality-of-life instrument with three scales (Urinary, Pelvic Organ Prolapse, and Colorectal-Anal). The PFIQ-7 is a validated instrument that is widely utilized in research in conjunction with the PFDI-20 to provide a comprehensive evaluation of the impact of pelvic floor disorders on quality of life, specifically how they affect activities, relationships, and feelings on a scale from not at all to quite a bit.
Time frame: 6 months
Patient Global Symptoms Control Rating Scale (PGSC)
A a single item adapted for purposes of this trial. It will state "My current treatment is giving me adequate control of my prolapse" and participants will be asked to select a response on a 5-point Likert scale ranging from (1) disagree strongly to (5) agree strongly
Time frame: 6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
A validated instrument to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence with 21 questions for sexually active women and 12 questions for non-sexually active women
Time frame: 6 months
Pessary outcomes
Will include continued use of pessary and number of unintentional pessary expulsions
Time frame: 6 months
Behavioral Outcomes
Will include a 5-point Likert scale ranging from (1) disagree strongly to (5) agree strongly about participants' ease of self-administered pessary insertion, ease of self-administered pessary removal, discomfort with self-administration of pessary insertion, and discomfort with self-administration of pessary removal
Time frame: 6 months
Participant view of importance of ability to self-maintain pessary
This outcome will be measured by the question "How important is it to you to be able to self-manage your pessary?" with response options on a 5-point Likert scale of 1-not at all important, 2-slightly important, 3-neutral, 4-moderately important, 5-very important.
Time frame: 6 months
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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