Comparing a new pessary system to standard pessary care for pelvic organ prolapse treatment
The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse
This study is testing a new pessary system to see if it works better than standard care for women with pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 9 sites (Birmingham, Alabama and 8 other locations) |
| Trial ID | NCT06634459 on ClinicalTrials.gov |
What this trial studies
This multi-centered, randomized controlled trial aims to evaluate the safety and efficacy of the novel Reia System, which includes a pessary and applicator, compared to standard pessary care among women with stage II-IV pelvic organ prolapse. A total of 182 participants will be recruited, all of whom are pessary naïve and symptomatic, and will be randomly assigned to either the Reia System or standard care. The study will involve four visits over six months, with the primary outcome being participant satisfaction measured at the six-month mark. Secondary outcomes will also be assessed to evaluate the overall effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women aged 18 and older with stage II-IV pelvic organ prolapse who are new to pessary use and prefer conservative management.
Not a fit: Patients with primary indications for pessary use related to stress urinary incontinence or those with prior pelvic surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and user-friendly option for managing pelvic organ prolapse in women.
How similar studies have performed: While this approach is novel, similar studies evaluating pessary systems have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 8 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- MedStar Health — Washington D.C., District of Columbia, United States (Recruiting)
- The University of Chicago — Northbrook, Illinois, United States (Recruiting)
- Dartmouth-Hitchcock — Lebanon, New Hampshire, United States (Recruiting)
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- Women & Infants Hospital in Rhode Island — Providence, Rhode Island, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Melissa G Goodwin
- Email: melissa.g.goodwin@medstar.net
- Phone: 202-877-3657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.