Reia Pessary for Pelvic Organ Prolapse

(ESCAPE Trial)

Overseen By Sophia E Allen

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Vaginal infections, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pessary, the Reia pessary, designed for women with pelvic organ prolapse (POP). The goal is to determine if this collapsible device allows patients to manage their condition at home, reducing the need for frequent doctor visits. Participants will either self-manage with the Reia pessary or continue office-based care. Women who currently use a pessary for stage II-IV POP and regularly visit their doctor are good candidates for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance home management of POP.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are being treated for vaginal infections, you must complete treatment and wait 2 weeks before joining the study.

What prior data suggests that the Reia pessary is safe for pelvic organ prolapse?

Research has shown that the Reia pessary, used for pelvic organ prolapse, is generally safe. Studies have found that collapsible pessaries, like the Reia, provide comfort for patients. These devices are inserted into the vagina to support pelvic organs and manage prolapse without surgery.

Previous research indicates that the collapsible design of similar pessaries simplifies insertion and removal, enabling patients to manage them independently. Studies have reported no major problems or complications, suggesting that the Reia pessary is well-tolerated.

Although information on long-term safety is limited, current evidence suggests that the Reia pessary can be a safe choice for those seeking to manage their condition independently. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Reia System pessary stands out because it offers a collapsible design that allows women to convert to self-management for pelvic organ prolapse, unlike traditional rigid pessaries that require regular office visits for adjustments and cleaning. This self-care approach empowers patients, giving them more control over their treatment and potentially reducing the inconvenience and cost of frequent doctor appointments. Researchers are excited about this innovation because it could significantly enhance patient comfort and satisfaction while maintaining effective management of the condition.

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

Studies have shown that the new Reia pessary is promising for treating pelvic organ prolapse. One study found that it fit well for 95.4% of patients, indicating that most people could use it without issues. Patients reported significant improvement in comfort while using it. In this trial, participants in the "Self-Care" arm will switch to the new, collapsible Reia pessary and transition to self-management for their care. The Reia pessary's collapsible design makes it easier to remove and more comfortable than some other options. Research indicates that this pessary improves the quality of life for those managing their care at home. Overall, the Reia pessary appears to be an effective and safe option for those dealing with prolapse. ^{4 6 7 8 9}

Who Is on the Research Team?

Kris Strohbehn, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adult women (18+) with Stage II-IV Pelvic Organ Prolapse who currently manage their condition with regular office visits. It's not suitable for those who don't wish to continue pessary management or have other primary reasons for using a pessary.

Inclusion Criteria

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

I have stage II-IV pelvic organ prolapse and want to keep using a pessary.

I am using a pessary for pelvic organ prolapse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to a new, collapsible pessary for self-management or continue with office-based care

6 months

Regular visits every 3-6 months for office-based care group

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Reia System pessary

Trial Overview The study compares two ways of managing pelvic organ prolapse: the new Reia System, which allows patients to manage their prolapse at home, and the standard practice of visiting a healthcare provider regularly (2-4 times per year).

How Is the Trial Designed?

Group I: Self-Care Experimental Treatment 1 Intervention

Subjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse.

Group II: Office-Care Active Control 1 Intervention

Subjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12610322/

Effectiveness of Vaginal Pessary Use in Improving Quality ... By enrolling 130 women—most with advanced prolapse—and demonstrating a 95.4% fitting success rate with significant improvements in symptom and ...

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

Effectiveness and safety of a novel, collapsible pessary for ... This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months.

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. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00503-5/fulltext

Clinical effectiveness of vaginal pessary self-management ... The primary clinical outcome measure for effectiveness was pelvic floor-specific quality of life at 18 months, measured using the Pelvic Floor ...

6. ajog.org ajog.org/article/S0002-9378(24)00097-8/fulltext

Effectiveness & safety of a novel, collapsible pessary for ... Objective. To assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse (POP) at three months. Methods.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232677.pdf

K232677 Trade/Device Name: Reia pessary The Reia pessary is a collapsible vaginal pessary for non-surgical treatment of pelvic organ prolapse. The. Reia pessary is reusable by a single ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/35/NCT04508335/Prot_000.pdf

Assessment of effectiveness and safety of a novel pessary ... Successful use of the Gellhorn pessary as a second- line pessary in women with advanced pelvic organ prolapse. Menopause. 2017;24(11):1277 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10697197/

A novel, collapsible, space-occupying pessary for the ... The study pessary (SP) is an investigational device designed with collapsible geometry to simplify insertion and removal for women with pelvic organ prolapse ( ...