Reia Pessary for Prolapse

(POMEGRANATE Trial)

Recruiting at 9 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

Trial Summary

What is the purpose of this trial?

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 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.

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 data supports the effectiveness of the Reia Pessary treatment for prolapse?

Research shows that pessaries, including the Gellhorn and ring types, are effective non-surgical treatments for pelvic organ prolapse, reducing symptoms and improving quality of life with minimal complications. They are considered low-risk and can be used successfully for both short- and long-term relief. ^{1 2 3 4 5}

What makes the Reia Pessary treatment unique for pelvic organ prolapse?

The Reia Pessary treatment is unique because it offers a non-surgical, customizable option for managing pelvic organ prolapse, using a flexible silicone device that can be fitted to individual anatomy, potentially improving comfort and effectiveness compared to standard pessaries. ^{1 2 4 5 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Symptomatic and anatomic improvement of pelvic organ prolapse in vaginal pessary users. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Successful use of the Gellhorn pessary as a second-line pessary in women with advanced pelvic organ prolapse. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Vaginal support pessaries: indications for use and fitting strategies. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Customized Pessary Fabrication Using Three-Dimensional Printing Technology. [2021]