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

Conditions

• Pelvic Organ Prolapse
• Prolapse

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Reia System — DEVICE
  Reia pessary
• Standard of Care Pessary — DEVICE
  Gellhorn pessary or ring with/without support without knob pessary

Study Details

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 Dates

Start date

Nov 1, 2024

Status verified

Jun 2025

Primary completion

Apr 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

218 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Satisfaction with treatment [ Time Frame: 6 months ]

Central Contacts

• Melissa G Goodwin
  202-877-3657
  [email protected]
• Alexis A Dieter
  [email protected]

Locations (9)

Find similar trials in Birmingham, AL

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