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

Last updated: March 27, 2025
Sponsor: Medstar Health Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

Standard of Care Pessary

Reia System

Clinical Study ID

NCT06634459
POM-110
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

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) (Seebelow 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 floorsurgery

  • 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 toprolapse

  1. Patients with acute vaginal infections will be eligible for enrollment 2 weeksafter completing treatment with resolution of symptoms

  2. OK to be on prophylactic/suppressive therapy for HSV

Study Design

Total Participants: 182
Treatment Group(s): 2
Primary Treatment: Standard of Care Pessary
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
October 30, 2026

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • MedStar Health

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • MedStar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • The University of Chicago

    Northbrook, Illinois 60062
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53711
    United States

    Active - Recruiting

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