NCT06634459 · Medstar Health Research Institute
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
(POMEGRANATE)
What this study is about
This multi-centered, randomly assigned controlled trial will evaluate the safety and effectiveness 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
- Vaginal, rectal or bladder malignancy
- Genitourinary infection requiring treatment (See below 1)
- Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2)
- Inflammatory bowel disease (Crohn's or ulcerative colitis)
- Pelvic or anorectal chronic pain
- Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
- Congenital malformation of the bladder, rectum or vagina
- Pregnant or planning pregnancy in the next 6 months
- Prior failure of pessary for POP
- History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse
- Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms
- OK to be on prophylactic/suppressive therapy for HSV
Where
- Birmingham, Alabama
- Palo Alto, California
- Washington D.C., District of Columbia
- Northbrook, Illinois
- Lebanon, New Hampshire
- Albuquerque, New Mexico
- Winston-Salem, North Carolina
- Providence, Rhode Island
- Madison, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations