Actively Recruiting
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Led by Medstar Health Research Institute · Updated on 2026-04-13
218
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking natal females 18 years of age or older
- Willing to self-maintain (insert/remove) pessary
- Pessary naive with Stage II-IV pelvic organ prolapse desiring conservative management with a pessary
- Primary indication for use of pessary is treatment of pelvic organ prolapse
You will not qualify if you...
- Primary indication for pessary use is for management of stress urinary incontinence
- Prior mesh-augmented prolapse repair (e.g., transvaginal mesh, sacrocolpopexy)
- Short vaginal length (total vaginal length less than 8 cm) or subjective vaginal narrowing
- Vaginal fistula (e.g., rectovaginal, vesicovaginal, or any fistula involving the vagina)
- Vaginal, rectal, or bladder malignancy
- Genitourinary infection requiring treatment
- Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis)
- Inflammatory bowel disease (Crohn's or ulcerative colitis)
- Pelvic or anorectal chronic pain
- Pelvic floor surgery within the past 6 months or planning 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 pelvic organ prolapse
- History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
MedStar Health
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
The University of Chicago
Northbrook, Illinois, United States, 60062
Actively Recruiting
5
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
6
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
7
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
8
Women & Infants Hospital in Rhode Island
Providence, Rhode Island, United States, 02903
Actively Recruiting
9
University of Wisconsin
Madison, Wisconsin, United States, 53711
Actively Recruiting
Research Team
M
Melissa G Goodwin
CONTACT
A
Alexis A Dieter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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