Pelvic Organ ProlapsePOMEGRANATENCT06634459

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

A study testing Reia System in people with Pelvic Organ Prolapse and Prolapse, run by Medstar Health Research Institute at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse, Prolapse
What is being tested?: Reia System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 218 participants
Where: 9 sitesUnited States
Study dates: 1 Nov 2024to Jan 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 16Show fewer

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
University of Wisconsin
Madison, Wisconsin, 53711
The University of Chicago
Northbrook, Illinois, 60062
Stanford University
Palo Alto, California, 94304
Women & Infants Hospital in Rhode Island
Providence, Rhode Island, 02903
MedStar Health
Washington D.C., District of Columbia, 20010
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse

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
Being tested: Reia System, Standard of Care Pessary
Medical subject headings: Pelvic Organ Prolapse, Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reia SystemDevice
Reia pessary
Standard of Care PessaryDevice
Gellhorn pessary or ring with/without support without knob pessary

Study groups in NCT06634459
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Standard of Care Pessary

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 6 months

Secondary outcomes (10)

Total self-management events
Defined as removing the pessary ≥ one time per 24-hour period over the six-month follow-up period, this outcome will be summed and divided by actual days of follow-up to accommodate minor variation across participants in the exact length of follow-up.
Measured: 6 months
Patient Global Impression of Severity (PGI-S)
A single item questionnaire to assess the patient's impression of disease severity. For purposes of this trial, the investigators have adapted the PGI-I to specifically ask about "prolapse" severity. It will ask participants to "Check the one number that best describes how the participant's prolapse condition is now" on a 4-point Likert scale ranging from (1) normal to (4) severe
Measured: 6 months
Patient Global Impression of Improvement (PGI-I)
A single item questionnaire to assess a patient's impression of change. For purposes of this trial, the investigators have adapted the PGI-I to specifically ask about "prolapse symptoms." It will ask participants to "Check the one number that best describes how the participant's prolapse condition is now, compared with how it was before the participant began this study" on a 7-point Likert scale ranging from (1) very much better to (7) very much worse
Measured: 6 months
Pelvic Floor Distress Inventory-20 (PFDI-20)
A 20-item condition-specific quality-of-life instrument with three scales (6-item Urinary Distress Inventory, 6-item Pelvic Organ Prolapse Distress Inventory, and 8-item Colorectal-Anal Distress Inventory) used to evaluate the impact of pelvic floor disorders on quality of life with a response scale from 0 (not present) to 4 (quite a bit bothersome).
Measured: 6 months
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
A 7-item condition-specific quality-of-life instrument with three scales (Urinary, Pelvic Organ Prolapse, and Colorectal-Anal). The PFIQ-7 is a validated instrument that is widely utilized in research in conjunction with the PFDI-20 to provide a comprehensive evaluation of the impact of pelvic floor disorders on quality of life, specifically how they affect activities, relationships, and feelings on a scale from not at all to quite a bit.
Measured: 6 months
Patient Global Symptoms Control Rating Scale (PGSC)
A a single item adapted for purposes of this trial. It will state "My current treatment is giving me adequate control of my prolapse" and participants will be asked to select a response on a 5-point Likert scale ranging from (1) disagree strongly to (5) agree strongly
Measured: 6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
A validated instrument to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence with 21 questions for sexually active women and 12 questions for non-sexually active women
Measured: 6 months
Pessary outcomes
Will include continued use of pessary and number of unintentional pessary expulsions
Measured: 6 months
Behavioral Outcomes
Will include a 5-point Likert scale ranging from (1) disagree strongly to (5) agree strongly about participants' ease of self-administered pessary insertion, ease of self-administered pessary removal, discomfort with self-administration of pessary insertion, and discomfort with self-administration of pessary removal
Measured: 6 months
Participant view of importance of ability to self-maintain pessary
This outcome will be measured by the question "How important is it to you to be able to self-manage your pessary?" with response options on a 5-point Likert scale of 1-not at all important, 2-slightly important, 3-neutral, 4-moderately important, 5-very important.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 2024Jan 2027

First posted10 Oct 2024
Study start1 Nov 2024
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 218 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06634459
Sponsor's protocol ID: POM-110
Acronym: POMEGRANATE
Status last verified: Jul 2026
First submitted: 2 Oct 2024
Last updated: 23 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 16021067
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.
PubMed 28589290
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.
PubMed 23632798
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.
PubMed 31078660
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.
PubMed 18929686
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.
Pinhero J, Bates D. Mixed Effects Models in S and S-plus: Springer; 2000.
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.
PubMed 20410783
Health UDo, Services H. Common Terminology Criteria for Adverse Events. Version 5.0. Published November 27, 2017. 2020.
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.
PubMed 36462059

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse
ClinicalTrials.gov ID: NCT06634459
Acronym / sponsor ID: POMEGRANATE / POM-110
Conditions: Pelvic Organ Prolapse, Prolapse
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 218 participants (estimated)
Lead sponsor: Medstar Health Research InstituteUniversity, hospital or other
Study start: 1 Nov 2024 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 10 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Reia System	Active comparator	Device: Reia SystemParticipants 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.
Standard Pessary Care	Active comparator	Device: Standard of Care PessaryParticipants receiving SPC will be fit with a Gellhorn pessary or ring with/without support without knob pessary per standard clinical protocol.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reia SystemReia pessary	Device	Reia System
Standard of Care PessaryGellhorn pessary or ring with/without support without knob pessary	Device	Standard Pessary Care

Primary outcome

Satisfaction with treatment
Time frame: 6 months
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).

10 secondary outcomes

Total self-management events
Time frame: 6 months
Patient Global Impression of Severity (PGI-S)
Time frame: 6 months
Patient Global Impression of Improvement (PGI-I)
Time frame: 6 months
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time frame: 6 months
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time frame: 6 months
Patient Global Symptoms Control Rating Scale (PGSC)
Time frame: 6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Time frame: 6 months
Pessary outcomes
Time frame: 6 months
Behavioral Outcomes
Time frame: 6 months
Participant view of importance of ability to self-maintain pessary
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Background: PubMed 16021067Barber 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.
Background: PubMed 28589290Constantine 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.
Background: PubMed 23632798Rogers 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.
Background: PubMed 31078660Harris 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.
Background: PubMed 18929686Harris 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.
BackgroundR Core. R Core Team (2020). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. Accessed December 20, 2021.
BackgroundPinhero J, Bates D. Mixed Effects Models in S and S-plus: Springer; 2000.
Background: PubMed 20410783Schulz 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.
BackgroundHealth UDo, Services H. Common Terminology Criteria for Adverse Events. Version 5.0. Published November 27, 2017. 2020.
Background: PubMed 36462059Strohbehn 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reia System in people with Pelvic Organ Prolapse and Prolapse, run by Medstar Health Research Institute at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06634459, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.