POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Purpose
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 182 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 the number of successful self-managed pessary removal events completed over the six-month time frame. Secondary outcomes will include validated surveys to assess quality of life, adverse events and satisfaction with treatment. Specific Aims Aim 1: To compare number of self-management events over a 6-month period 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, 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 satisfaction with treatment and 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
- Pelvic Organ Prolapse
- Prolapse
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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 - Vesicovaginal or rectovaginal fistula - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized in a 1:1 ratio to receive either (1) the Reia System (RS) or (2) standard pessary care (SPC).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Reia System |
Participants receiving the commercially available RS will be fit with one of three available pessary sizes and will receive an applicator corresponding to their pessary size. |
|
|
Active Comparator Standard Pessary Care |
Participants receiving SPC will be fit with a Gellhorn pessary or ring with/without support without knob pessary per standard clinical protocol. |
|
Recruiting Locations
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute