Reia Pessary for Prolapse

(POMEGRANATE Trial)

Recruiting at 10 trial locations

Overseen By Alexis A Dieter

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: Stress urinary incontinence, Vaginal malignancy, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

182 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Reia System, designed to help women manage pelvic organ prolapse (POP), a condition where organs like the bladder or uterus slip from their normal position. Researchers aim to determine if the Reia System is safer and more effective than the standard pessary care options currently available. Women who have never used a pessary, have moderate to severe POP, and seek a non-surgical treatment option might be suitable for this study. The trial compares satisfaction, ease of use, and quality of life between the new system and traditional treatments. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance non-surgical treatment options for POP.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing treatment for vaginal infections, you must complete it and have no symptoms for 2 weeks before joining. You can continue prophylactic therapy for HSV.

What prior data suggests that the Reia System is safe for home use in women with pelvic organ prolapse?

Research has shown that the Reia System, a new device for supporting pelvic organs, is safe to use. Earlier studies found that the Reia device made insertion and removal less painful, enhancing user comfort. It also improved patients' quality of life by reducing symptoms of pelvic organ prolapse.

Regarding safety, these studies reported no major negative effects. Participants generally tolerated the device well, experiencing no significant side effects. The Reia device's design makes it easier to use, likely contributing to its safety and comfort.

Overall, current research suggests that the Reia System is a safe choice, especially compared to traditional devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Reia System is unique because it offers a tailored fit with three different pessary sizes and includes a corresponding applicator for easier insertion and removal, potentially enhancing user comfort and satisfaction. Unlike standard pessary care, which often involves a Gellhorn or ring pessary that may not provide a perfect fit for all users, the Reia System aims to personalize treatment for those with pelvic organ prolapse. Researchers are excited about this treatment because it could improve adherence and outcomes by addressing the common challenges of fit and ease of use associated with traditional pessary options.

What evidence suggests that the Reia System is effective for pelvic organ prolapse?

Research has shown that the Reia System, one of the treatments studied in this trial, could effectively manage pelvic organ prolapse (POP). In studies, the Reia pessary reduced the impact of prolapse symptoms on quality of life by 48%. It also made insertion 42% less painful and removal 33% less painful. Designed for comfort and ease of use, the Reia System may help users manage their condition better. These findings suggest that the Reia System could be a promising option for those seeking effective relief from POP symptoms. Participants in this trial will receive either the Reia System or Standard Pessary Care, which includes a Gellhorn pessary or ring pessary. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

The POMEGRANATE Trial is for women with stage II-IV pelvic organ prolapse who have not used a pessary before. They must be experiencing symptoms and choose to manage their condition with a vaginal pessary. The trial excludes certain details which are not provided here.

Inclusion Criteria

I am willing to manage my pessary by myself.

I use a pessary for pelvic organ prolapse.

I am a woman over 18 years old and speak English.

Exclusion Criteria

I have had pelvic floor surgery in the last 6 months or plan to.

Pregnant or planning pregnancy in the next 6 months

I was born with a malformation of the bladder, rectum, or vagina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Reia System or standard pessary care for pelvic organ prolapse management

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety, efficacy, and quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reia System
• Standard of Care Pessary

Trial Overview

This study compares the Reia System, including a novel pessary and applicator, to standard care (Gellhorn or ring) in managing pelvic organ prolapse. Women will be randomly assigned to either group and will participate in four visits over six months to evaluate self-management of the device.

How Is the Trial Designed?

Group I: Reia System Active Control 1 Intervention

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.

Group II: Standard Pessary Care Active Control 1 Intervention

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

Reia System is already approved in United States for the following indications:

Approved in United States as Reia Pessary for:

• Temporary, non-surgical management of Pelvic Organ Prolapse

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Published Research Related to This Trial

Flexible silicone vaginal support pessaries are a low-risk and effective treatment option for managing symptoms of pelvic organ prolapse.

The article provides clinical recommendations and evidence regarding the indications for use, selection of pessaries, and proper fitting techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal support pessaries: indications for use and fitting strategies. Atnip, S., O'Dell, K.[2013]

A survey of 322 members from the International Urogynaecology Association revealed that most clinicians view shelf and Gellhorn pessaries as effective first-line treatments for pelvic organ prolapse (POP).

There is significant variation in practice regarding how often these pessaries should be changed, with 35% of respondents suggesting every 3 months and 31% every 6 months, indicating a need for evidence-based guidelines to standardize care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How often should shelf/Gellhorn pessaries be changed? A survey of IUGA urogynaecologists. Khaja, A., Freeman, RM.[2021]

The Gellhorn pessary was successfully fitted in 82.3% of women with advanced pelvic organ prolapse who previously failed to retain a ring pessary, demonstrating its efficacy as a second-line treatment option.

After 3 months, 70.8% of participants continued using the Gellhorn pessary, although mild complications like vaginal erosion were reported; factors such as higher body mass index and previous surgeries were linked to discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful use of the Gellhorn pessary as a second-line pessary in women with advanced pelvic organ prolapse. Deng, M., Ding, J., Ai, F., et al.[2018]

Pessaries are a low-risk and effective non-surgical treatment for pelvic organ prolapse, suitable for patients who either do not want surgery or need a diagnostic tool to assess surgical outcomes.

With proper training, most patients can be successfully fitted with a pessary and manage it themselves, leading to high patient satisfaction and effective symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pessary use and management for pelvic organ prolapse. Atnip, SD.[2009]

A custom-made pessary, created using a 3D printer and medical-grade silicone, was successfully used in a patient with stress urinary incontinence (SUI) who had previously failed commercial pessary fittings.

The patient experienced no discomfort or leakage during a 48-hour trial, indicating that 3D-printed pessaries can provide a comfortable and effective alternative for women with unique anatomical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized Pessary Fabrication Using Three-Dimensional Printing Technology. Barsky, M., Kelley, R., Bhora, FY., et al.[2021]

In a study of 50 women with pelvic organ prolapse, the use of a ring pessary for at least 4 months led to a significant reduction in pelvic organ prolapse measurements, indicating its effectiveness in managing the condition.

The use of the ring pessary also resulted in improved quality of life for the participants, demonstrating its dual benefit of symptom relief and enhanced well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic and anatomic improvement of pelvic organ prolapse in vaginal pessary users. Mendes, LC., Bezerra, LRPS., Bilhar, APM., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04508335

NCT04508335 | Feasibility Study of the Reia Vaginal Pessary

The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S000293782400591X

Effectiveness and safety of a novel, collapsible pessary for ...

The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10562599/

A randomized controlled study comparing the objective ...

With ProVate, in 96.3% of participants, there was prolapse reduction to POP-Q stage 0 or 1, over 98% of them had a one-stage prolapse reduction, and in over 91 ...

4.

ajog.org

ajog.org/article/S0002-9378(24)00591-X/abstract

Effectiveness and safety of a novel, collapsible pessary for ...

Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and ...

5.

reiahealth.com

reiahealth.com/research

Reia Pessary Clinical Trial Results

Significantly reduced the impact of prolapse symptoms on quality of life by 48%. Significantly reduced pain during insertion by 42% and during removal by 33%.

6.

medstarhealth.org

medstarhealth.org/blog/pelvic-organ-prolapse-device-research

Research Explores New Options for Pelvic Organ Prolapse ...

In earlier trials, the Reia pessary significantly enhanced patients' quality of life, reduced pain and discomfort, and increased the number of ...