Pelvic floor health is a critical aspect of a woman’s overall wellbeing. The pelvic floor muscles, located at the base of the pelvis, support the bladder, uterus, and rectum. These muscles also play a vital role in sexual function, childbirth, and bowel and bladder control. Weak or dysfunctional pelvic floor muscles can lead to a range of health issues, including urinary incontinence, pelvic organ prolapse, and sexual dysfunction.
Studies conducted between 2005 and 2010 report that roughly 25% of U.S. women are affected by pelvic floor disorders – a percentage that, based on more recent studies on specific pelvic floor conditions, is likely under-reported and deserving of updated research. In the U.K., recent research by The Royal College of Obstetricians and Gynaecologists revealed that over 60% of UK women have at least one symptom of poor pelvic floor health, with nearly 1 in 4 women never having done pelvic floor exercises that can prevent and improve symptoms.
Despite the importance of pelvic floor health, many women lack education and awareness about this topic. In many cultures, it is considered taboo or embarrassing, leading to shame and a lack of discussion about it. Furthermore, the medical community has historically placed less emphasis on women’s health concerns, leading to a lack of research and education about pelvic floor health specifically.
Pelvic Floor And Urinary Incontinence
For Lydia Zeller, CEO of U.S.-based women’s health company Flyte, awareness is one of the biggest challenges women with this problem face. “Women are uncomfortable bringing up these topics to their healthcare providers and when they do, too many have been dismissed without guidance on how to improve their symptoms. We have only recently begun to shine a light here and have more open conversations … and collectively we have more work to do. It’s almost a case of what challenges don’t women with pelvic floor problems face,” she says.
Specific to urinary incontinence (UI), the statistics paint a stark picture: UI is linked to more than double the rate of severe depression and is included just behind Alzheimer’s and stroke in the three chronic conditions that most adversely impact the quality of life.
“If you are unaware that effective solutions exist, you cannot advocate for yourself. And even then, self-advocacy is a difficult path! It is challenging for people to evaluate options when they may not fully understand the underlying issues or where to go for information. Even more problematic, women often deprioritize their own health, focusing first on their families. And women, especially working mothers, are busy. It can be dauntingly time-consuming to navigate the journey to effective care,” explains Zeller.
As the CEO of Flyte, Zeller has made it her mission to empower both women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte, is an FDA-cleared, novel in-home treatment for stress urinary incontinence and pelvic floor muscle strengthening. It delivers a treatment modality called mechanotherapy to restore continence and improve pelvic muscle tone.
“In our two clinical studies, we achieved continence rates and durability comparable to surgery in the fastest in-home treatment available. Specifically, we achieved continence in 83% of women in just five minutes a day for six weeks in the privacy of their home – and 77% of participants were still continent two years later. That achievement is a breakthrough from a technology standpoint – but even more importantly, it is life-changing for our users,” adds Zeller.
Research from the Mayo Clinic shows that 50%, if not more, of U.S. women, suffer some form of bladder leaks. And 2022 research found that 1 in 2 suffers stress (SUI) or mixed (MUI) urinary incontinence.
“It is completely unacceptable that a problem this large has historically been kept quiet and stigmatized, with women being led to believe that bladder leaks are part of being a mom or part of growing older. Bladder leaks are very common – but they are not normal and women do not need to accept them as part of life.”
On the B2B side, Flyte partners with clinicians – including digital/virtual health companies, health systems, and private practices, as well as select e-commerce and retail companies providing products and services to moms, athletes, and women navigating menopause.
For Zeller, there is no doubt that pelvic health will benefit from a continued trend toward digital, virtual, and in-home care options. These options increase access, enabling women to fit care into their lives and enabling clinicians to expand their clinic walls to meet women where they are and deliver conservative care at scale. The result is higher-value care.
“In addition to the expansion of standard fee-for-service and reimbursement codes, we need to advocate for value-based models like maternity bundles that include post-partum pelvic floor care. We also need to push for better screening followed by navigation to appropriate resources and care,” she concludes.
Pelvic Floor Diagnostics And Treatments
Allison L. Watkins, CEO of Watkins-Conti Products, Inc., a U.S.-based healthcare company developing a pipeline of diagnostics and treatments that address women’s reproductive, sexual, and pelvic health, experienced stress urinary incontinence (SUI) following the birth of her 11-pound baby. Frustrated by limited options, she wanted to develop something more discreet, convenient, and comfortable.
To her, the current marketplace for urinary incontinence solutions is exceptionally daunting, and pelvic floor rehabilitation is effective but the strict regimen and frequency can deter patient compliance. “We as a society are only now beginning to have conversations about menopause and pelvic health – separate and distinct from reproduction. Women are more than the sum of their baby parts, and we have important health needs that last the duration of our lives, not just during the relatively short window of fertility,” she shares.
The company’s flagship product, Yōni.Fit, is a patient-designed medical device created to help relieve the symptoms of SUI – the involuntary leakage of urine during physical activity or exerting pressure on the bladder (such as sneezing, running, etc.). “Apart from negatively impacting the quality of life and emotional wellbeing, it also may get worse over time if untreated, potentially leading to pelvic organ prolapse (when organs slip from their original position).“This means the sooner the woman treats her symptoms, the sooner she can help restore her quality of life,” she adds.
Manufactured with 100% medical grade silicone, Yōni.Fit is designed to gently support the urethra (the bladder neck) to stop involuntary urine leakage while not interfering with voluntary urination. The device is a soft vaginal insert that is designed to be reusable for up to 30 days and easy to clean. The company has raised over $6 million to date in funding from angel investors and VCs, and Watkins’s priority project now is obtaining FDA approval for Yōni.Fit following the recent completion of a national clinical trial by Urogynecologists at Stanford, NYU, and Jefferson Health.
“I literally wake up in the middle of the night with more and more ideas of how the Yoni.Fit platform can also be utilized for diagnostics and treatments. This is particularly relevant for women in remote areas where a simple device is more realistic than a surgical intervention or where there is no electricity to power plug-in devices.”
Putting The Bladder Care Into The Mainstream
Peony Li, founder and CEO of Jude, a U.K.-based women’s health company, “on a mission to put bladder care into the mainstream”, shared with me how she understands that Kegel exercises are not the be-all and end-all for women. This applies particularly to the 10% of women who have a hypertonic pelvic floor and women who suffer from overactive bladder and nocturia. “In addition to that, medication targeting bladder health is extremely intolerable, especially with more than half of women coming off the drugs due to side effects, and its association with the early onset of dementia,” she adds.
This is why their hero product – supplements supporting overactive bladder symptoms, also strengthening the pelvic floor by restoring collagen production and relieving nocturia which is waking up at night feeling the urge to go, have been a game changer for many of their customers so far, especially postnatal mothers and women going into perimenopause across to post-menopause years of their lives.
Li shares how today we only have three monopolies producing diapers and pads that only manage unwanted symptoms of an underlying health issue. On top of that, the narrative that has been widely accepted has been making women accept incontinence and bladder issues as a normal part of aging and a natural consequence of childbirth. “The lack of options is the main reason why we wanted to build a category around bladder care.”
A recently published report by The Royal College of Obstetricians and Gynaecologists is a great starting point for women in the U.K., explained Li. She explains how young mothers have also come to the realization that incontinence and prolapse aren’t something they should just accept. “However, from our day-to-day interaction with women in their 50s-70s, pelvic floor, and bladder health are still a topic in the closet. In fact, this demographic is usually forgotten and extremely underserved. The work we do with older populations is vital to empowering them to maintain independence for longer.”
So far, the startup has received £2 million from venture capital funds that specialize in consumer and health, and a clinical trial is on the way in 2023 to further their research in functional food and the role hormones play in improving long-term bladder health. Li shares how they will also be launching a large-scale patient data collection to quantify the anecdotal correlations between lifestyle factors (weight, diet, and more), medical history, and bladder health. “In particular, we are partnering with the Endometriosis Foundation to understand the overlap between endometriosis and incontinence.”
Pelvic Pain And Mental Health
Claudia Chisari, Ph.D., founder and CEO of Femspace, which provides digital care for pelvic pain (specialist psychological and pelvic floor physiotherapy) in one integrated place, has carried out her Ph.D. developing digital solutions for pelvic pain at King’s College London. Dr. Chisari is an internationally recognized expert in persistent pelvic pain and vulvodynia. She also holds an Honorary Academic position at King’s College London and is a research advisor of the Vulvar Pain Society.
When looking at data from thousands of people with pelvic pain, almost all the people she has spoken to reported significant issues with health access, and that their pain has been systematically invalidated and ignored.
“They also reported the lack of and need for solutions to support their mental health as well as physical health. Recent research by Nurofen reports a similar picture. While women are more in pain than men, and more severely too, 56% reported that their pain was ignored or dismissed. This is known as the Gender Pain Gap. That’s what prompted me to leverage all the knowledge and years of research to provide a concrete solution: making pelvic pain care accessible to all and empowering people to take control of their health again,” Chisari explains.
She continues to highlight that, despite the lack of research in funding for women’s health space, some areas such as pelvic floor health have started coming out of the closet in recent years.
“Firstly, there has been more research and understanding of the importance of the pelvic floor in women’s health, particularly pelvic pain. Secondly, there has been a cultural shift toward having more open conversations and awareness around pelvic floor health. Good pelvic floor health translates not only to better sex life but also reduction and prevention of pain, better mobility, and overall improved quality of life. Additionally, media can be a powerful tool in raising awareness about pelvic floor health by featuring stories and interviews with people with expertise in pelvic floor health.”
Despite this, there is still work to be done to raise more awareness and understanding about this topic. Pelvic floor health means different things to different people, depending on their health needs. She highlights how, when thinking about pelvic floor health, there’s still a misconception that they are only Kegel’s exercises, aiming to strengthen the pelvic floor muscles. “These are still blindly given to anyone who experiences pain. However, if the pelvic floor muscles are already tense or overactive (which often happens in pelvic pain conditions like Vulvodynia), performing Kegels exacerbates the pain and discomfort.”
Backed by Barclays, AccellerateHer, and King’s College London, Chisari is currently working on expanding Femspace’s product offering and making it more and more personalized. “We are currently partnering with clinics, women’s health organizations, and sexual health companies with a shared vision of improving women’s health and pelvic floor health,” she concludes.