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Compares treatment options for Pelvic Organ Prolapse
Official title POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
ClinicalTrials.gov ID: NCT06634459
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Northbrook, Illinois, United States
- Lebanon, New Hampshire, United States
- Albuquerque, New Mexico, United States
- Winston-Salem, North Carolina, United States
- Providence, Rhode Island, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Northbrook, Illinois, United States; Lebanon, New Hampshire, United States; Albuquerque, New Mexico, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.