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

Running, not enrolling · Not applicable

Conditions studied: Pelvic Organ Prolapse, Prolapse

In brief

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.

Key facts

Study ID: NCT06634459
Run by: Medstar Health Research Institute
People needed: 218
Starts: 2024-11-01
Expected to finish: 2027-01-01
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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)
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 it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Stanford University — Palo Alto, California, United States
MedStar Health — Washington D.C., District of Columbia, United States
The University of Chicago — Northbrook, Illinois, United States
Dartmouth-Hitchcock — Lebanon, New Hampshire, United States
University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
Women & Infants Hospital in Rhode Island — Providence, Rhode Island, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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