Beyond the Pomegranate: Research Explores New Options for Pelvic Organ Prolapse Care.

MedStar Health Research Institute is leading a multicenter randomized trial of a new pessary device that could help more patients access care for pelvic organ prolapse.

Prolapse of the pelvic organs has challenged women for centuries, and treatment methods date back to the beginning of history. Ancient Greek texts describe using half a pomegranate fruit soaked in wine to help support pelvic organs when the pelvic floor muscles weaken. Today, safe devices called pessaries serve this purpose. They are made of medical silicone—no need for fruit or wine.  

At MedStar Health Research Institute, we’re leading a randomized, multicenter study of a new kind of pessary that could be easier for patients to manage. 

Standard modern pessaries can help support the pelvic organs, but they have drawbacks. Some require appointments 2-4 times a year with a provider to remove and maintain the device. While most patients can find a comfortable fitting pessary, patients commonly find the insertion and removal process burdensome and uncomfortable, leading to difficulty in self-managing their pessary.

Reia is a medical device start-up company that has created a new pessary with the help of urogynecologists. Their latest design came from recognizing that a collapsible pessary could enable easier insertion and removal, making patients more comfortable and more likely to self-manage the device and avoid the extra visits. 

Our research trial, underway across the country, is investigating this new device to learn whether its design makes it easier for patients to self-manage their pessary at home, eliminating the need for regular clinic visits and improving day-to-day comfort.

182 patients to help test a new type of pessary.

The Reia pessary comes in three sizes because all bodies are different. It’s folded inside a tampon-like applicator and deploys like an umbrella inside the vagina to support the pelvic organs. 

To determine if this new device is better for patients, we’ve designed a multicenter, randomized clinical trial that will enroll 182 patients at nine sites across the U.S. A Small Business Innovation Research grant from the National Institutes of Health funds the trial.                   

Too often, research into pelvic floor disorders such as pelvic organ prolapse has involved mostly non-Hispanic white participants. Our study and carefully selected partner sites are designed to enroll a highly representative selection of participants across the United States. 

Patients who enroll in the trial will be randomly selected for the Reia or a traditional pessary therapy. They will complete online surveys and questionnaires at various time points throughout the trial, with a final follow-up appointment at six months. 

We’ll collect data on four critical questions about the Reia pessary over six months:

• Did it enable patients to self-manage better than a standard device?

• Does it help patients make fewer fitting, adjustment, and management visits than a standard pessary?

• Are patients more satisfied with it than a standard pessary?

• Do patients have more or fewer unwanted side effects with it compared to a standard pessary device?

In earlier trials, the Reia pessary significantly enhanced patients’ quality of life, reduced pain and discomfort, and increased the number of patients who could self-manage their pessary. If we meet our goal to complete enrollment by the fall of 2025, results should be available by fall 2026.

Signs of pelvic organ prolapse.

In the U.S., a woman has about a 1 in 8 chance of experiencing pelvic organ prolapse in her lifetime. It can happen at any age but is more commonly seen after menopause as women age. 

Typically, the pelvic floor connective tissue and muscle line the bottom of the abdominal cavity to support the pelvic organs (bladder, uterus/vagina, and rectum/bowel) above them like a trampoline. When this support becomes weakened or damaged, commonly due to age, vaginal childbirth, or trauma, the pelvic organs can bulge into the vaginal canal or even come outside the vulva or vaginal opening. 

Most patients don’t have symptoms until the prolapse is at or outside of the vaginal opening. When they appear, symptoms often can include:

• Seeing or feeling a bulge sticking out of the vagina

• Feeling pressure or fullness in the pelvis that may worsen when coughing, exercising standing, or at the end of the day

• Problems with leaking urine or difficulty emptying the bladder or bowels 

• Difficulty inserting tampons
  
  

Pelvic organ prolapse treatment is available.

Many patients suffer from symptoms of pelvic floor disorders in silence. I strongly encourage them to seek care – effective treatment is available! Urogynecologists, specialists with specific training in diagnosing, managing, and treating pelvic floor disorders, are here to help.

Pelvic floor physical therapy, including exercises known as “Kegels,” can help to strengthen the abdominal and pelvic muscles to help reduce early symptoms; however, more definitive treatment comes in the form of a pessary or surgery. Many patients choose a pessary to manage their symptoms, while other patients elect to undergo surgery to rebuild the support to the internal organs. 

Our MedStar Health urogynecology team of clinicians and researchers is at the forefront of understanding how to help women manage pelvic floor conditions, and we are leaders within our field working to help women who suffer from these common conditions every day. This study is one example of how we’re advancing health in our communities and helping more patients access the treatment they need.