POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Oct 8, 2024

Keywords

ClinConnect Summary

The POMEGRANATE Trial is studying a new device called the Reia System, which includes a pessary (a supportive device inserted into the vagina) designed to help women with pelvic organ prolapse (POP). This trial will compare the Reia System to the standard pessary treatment to see which one is safer and more effective for women experiencing this condition. The study will involve 182 women who are new to using a pessary and have moderate to severe POP. To be eligible, participants need to be at least 18 years old, speak English, and be willing to learn how to insert and remove the pessary themselves.

Participants in the trial will attend four visits over six months, where researchers will assess how well they can manage their pessary, how satisfied they are with the treatment, and if they have any side effects. The main goal is to find out how many women can successfully manage their pessary on their own over the six months. This study is important as it aims to improve the quality of life for women with POP by exploring new treatment options.

Gender

FEMALE

Eligibility criteria

• 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
• • 1. Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms
• • 2. OK to be on prophylactic/suppressive therapy for HSV