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

NCT06634459 | Recruiting DMC FDA Device

• 1 other identifier: POM-110
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 9

Brief 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 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

Pelvic Organ Prolapse; Prolapse

Outcome Measures

Primary Outcomes (1)

• Satisfaction with treatment

  The primary outcome will be measured by participant response to the question "How satisfied or unsatisfied are you with your ability to use and manage the pessary provided to you?" with response collected via VAS ranging from "0mm = very unsatisfied" to "100mm = very satisfied" with 50mm = neutral (neither satisfied nor unsatisfied).

  6 months

Secondary Outcomes (10)

• Total self-management events

  6 months

• Patient Global Impression of Severity (PGI-S)

  6 months

• Patient Global Impression of Improvement (PGI-I)

  6 months

• Pelvic Floor Distress Inventory-20 (PFDI-20)

  6 months

• Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

  6 months

Study Arms (2)

Reia System

ACTIVE COMPARATOR

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.

Device: Reia System

Standard Pessary Care

ACTIVE COMPARATOR

Participants receiving SPC will be fit with a Gellhorn pessary or ring with/without support without knob pessary per standard clinical protocol.

Device: Standard of Care Pessary

Interventions

Reia System DEVICE

Reia pessary

Reia System

Standard of Care Pessary DEVICE

Gellhorn pessary or ring with/without support without knob pessary

Standard Pessary Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MedStar Health

Washington D.C., District of Columbia, 20010, United States

RECRUITING

The University of Chicago

Northbrook, Illinois, 60062, United States

RECRUITING

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

RECRUITING

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Women & Infants Hospital in Rhode Island

Providence, Rhode Island, 02903, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53711, United States

RECRUITING

Related Publications (10)

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Constantine ML, Pauls RN, Rogers RR, Rockwood TH. Validation of a single summary score for the Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR). Int Urogynecol J. 2017 Dec;28(12):1901-1907. doi: 10.1007/s00192-017-3373-9. Epub 2017 Jun 6.

  PMID: 28589290 BACKGROUND

• Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kammerer-Doak DN, Pauls RN, Parekh M, Ridgeway B, Jha S, Pitkin J, Reid F, Sutherland SE, Lukacz ES, Domoney C, Sand P, Davila GW, Espuna Pons ME. A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1091-103. doi: 10.1007/s00192-012-2020-8. Epub 2013 Apr 30.

  PMID: 23632798 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• R Core. R Core Team (2020). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. Accessed December 20, 2021.

  BACKGROUND

• Pinhero J, Bates D. Mixed Effects Models in S and S-plus: Springer; 2000.

  BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.

  PMID: 20410783 BACKGROUND

• Health UDo, Services H. Common Terminology Criteria for Adverse Events. Version 5.0. Published November 27, 2017. 2020.

  BACKGROUND

• Strohbehn K, Wadensweiler P, Hanissian P. A novel, collapsible, space-occupying pessary for the treatment of pelvic organ prolapse. Int Urogynecol J. 2023 Jan;34(1):317-319. doi: 10.1007/s00192-022-05415-y. Epub 2022 Dec 3. No abstract available.

  PMID: 36462059 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Melissa G Goodwin

CONTACT

202-877-3657; melissa.g.goodwin@medstar.net

Alexis A Dieter

CONTACT

alexis.a.dieter@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either (1) the Reia System (RS) or (2) standard pessary care (SPC).

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)