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Start-up secures FDA clearance for stress urinary incontinence device

The device can be used during a specific activity or up to 12 hours for general control over symptoms

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Allison L. Watkins, founder and CEO of Watkins-Conti / Source: watkinscontiproducts.com

The US women’s health start-up Watkins-Conti has obtained 510(k) clearance from the US FDA for its stress urinary incontinence device. 

Yōni.Fit is a device intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women 18 years and older.

The silicone device is a soft vaginal insert that aims to reduce urine leaks without interfering with voluntary urination. It is self-administered and can be used during a specific activity or up to 12 hours for general control over symptoms.

The FDA clearance represents a “substantial milestone” in non-surgical options for the temporary management of urinary incontinence, a condition estimated to affect about one in three women in the US at some point in their lives.

Allison L. Watkins, founder and CEO of Watkins-Conti, said: “My lived experience as a new mother with SUI gave me the inspiration for Yōni.Fit.

“The options available to me at the time did not complement my lifestyle as a working mom with two small children.

“Listening to patients on their journey and innovating accordingly is paramount. I am committed to developing even more solutions for women’s pelvic health, using the Yōni.Fit device as a self-care platform that could potentially include diagnostics and drug delivery.”

Fifty-eight participants were enrolled in a randomised, controlled study of Yōni.Fit in women with SUI. The study was conducted by urogynaecologists at Stanford, NYU Langone, and Jefferson Health.

Of the participants completing the evaluation phase, a significantly higher percentage experienced clinically meaningful reduction in 12-hour pad weights with the Yōni.Fit device compared to the control device.

Karolynn T. Echols, director and associate professor of female pelvic medicine and reconstructive surgery at Thomas Jefferson University and an investigator in the Yōni.Fit clinical study, said: “My patients with stress urinary incontinence want a solution that is effective and convenient – one that accommodates the reality of their busy lives and does not interfere with voluntary urination.

“The cost and downtime associated with surgery can be prohibitive for some women.”

Dr Kate C. Arnold, chief medical officer of Watkins-Conti, added: “I believe Yōni.Fit will be an appealing and effective self-care solution for patients who value convenience and want to be in control of their pelvic health.

“We are committed to helping all women, including those in rural areas and in medically underserved communities, where access to surgery would be challenging.”

Ross Watkins, president of Watkins-Conti, shared: “With this FDA clearance, Watkins-Conti is now positioned to help this important and underserved market.”

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Common cancer marker may play active role in preventing the disease, study finds

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Ki-67, a protein used to measure tumour growth, may also help prevent chromosome errors that drive cancer, a study suggests.

The findings could change how scientists view Ki-67, a marker commonly used in breast cancer and other tumours to assess how quickly cancer cells are growing.

Researchers found the protein may help preserve genome stability by maintaining the structural integrity of centromeres, key parts of chromosomes that help ensure DNA is shared correctly during cell division.

The research was led by professor Paola Vagnarelli at Brunel University of London in collaboration with scientists at the University of Edinburgh and the Technical University of Berlin.

Professor Vagnarelli said: “Doctors already measure Ki-67 to see how aggressive a cancer might be. But our results suggest it is actually helping maintain genome stability.

“That means it may be more than a marker. It could potentially also be a therapeutic target.”

The study examined three proteins that attach to chromosomes during cell division and help rebuild the molecular system that tells each new cell what kind of cell it is.

Every human cell carries identical DNA. What makes a liver cell different from a brain cell is which genes are switched on and which are kept inactive.

When a cell divides, that entire system of switches must be rebuilt. The three proteins involved in this process were Ki-67, Repo-Man and PNUTS.

Vagnarelli’s team developed a method that individually removes each protein from a living cell at the precise point of division. Older techniques could not isolate that moment cleanly.

They found that cells rely on all three proteins to reset themselves after division, but each failed in a different way when removed.

Without PNUTS, gene activity spiralled out of control and thousands of genes switched on at once.

Without Repo-Man, cells escaped safety checkpoints that usually stop damaged or abnormal cells from continuing to divide.

“What we didn’t expect was how clean the separation was,” said Vagnarelli.

Each protein fails in its own specific way. There is no redundancy, no safety net. Which means there are three separate points at which this process can go wrong.

“When the system breaks down, cells can emerge with the wrong number of chromosomes. That condition, called aneuploidy, is seen in disorders such as Down syndrome and in many cancers.

“We also found that these chromosome errors can trigger inflammatory signals inside the cell.”

Aneuploidy means a cell has too many or too few chromosomes, which can disrupt normal growth and function.

Inflammatory signals are chemical messages that can make a cell behave as if it is responding to injury or infection.

“These cells behave almost as if they are under attack,” said Vagnarelli.

“The immune response switches on because the genome is unstable.

“That link between chromosome imbalance and inflammation could help explain patterns we see in several diseases.”

The researchers said the findings may help cancer scientists better understand how chromosome instability, loss of gene regulation and cells dividing before they are ready contribute to tumour growth.

They said understanding the normal machinery that prevents these errors may help researchers find ways to push cancer cells into making mistakes they cannot survive.

“We now have a clearer map of the machinery that resets the cell after division,” said Vagnarelli.

“That knowledge gives us a starting point for thinking about new therapeutic approaches.”

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Abdominal obesity may lead to more severe menopause symptoms – study

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Abdominal obesity may lead to worse menopause symptoms, including forgetfulness, irritability and night sweats, a new study suggests.

The findings point to a possible link between fat stored around the waist and more severe midlife symptoms.

Researchers said waist-to-height ratio could help identify women who may benefit from more targeted support.

Dr Monica Christmas is associate medical director for The Menopause Society.

Christmas said: “Unintended weight gain during the menopause transition, especially in the midsection, is one of the most commonly reported complaints, with the most significant gains experienced in the years leading up to the final menstrual period and a couple of years after.

“This not only affects self-image but also imposes negative health risks and, as the study highlights, is associated with higher prevalence and severity of menopause symptoms.”

The study used data from more than 1,100 women who took part in the Study of Women’s Health Across the Nation.

Abdominal obesity is a build-up of fat around the waist. It often includes visceral fat, which is deep, active fat surrounding internal organs.

This type of fat releases inflammatory proteins and toxic fatty acids that can contribute to insulin resistance, cardiovascular disease, high blood pressure and a higher risk of some cancers.

Insulin resistance means the body does not respond properly to insulin, the hormone that helps control blood sugar.

The Menopause Society said abdominal obesity is estimated to affect more than 60 per cent of menopausal women.

As oestrogen levels fall during menopause, women tend to store more fat around the waist rather than the hips, even if their overall weight does not change.

The researchers noted that obesity patterns and menopause symptom burden can vary by region, but research into the effect of abdominal obesity on these symptoms remains limited.

They also said earlier studies have mainly looked at single symptoms, rather than how symptoms connect with each other.

In this study, researchers used network analysis, a method that looks at how symptoms are linked, to compare symptom patterns in women with and without abdominal obesity.

They identified abdominal obesity using waist-to-height ratios, which compare waist size with height and can be used as a simple measure of health risk linked to body fat around the middle.

The researchers concluded that women with abdominal obesity had both a higher prevalence and greater severity of a range of symptoms, as well as a distinct symptom network structure.

In particular, women with abdominal obesity reported a higher prevalence and greater severity of dizziness, hot flashes and night sweats than women without abdominal obesity.

Sleep disturbances and palpitations were also reported more often in women with abdominal obesity. Palpitations are feelings of a fast, fluttering or pounding heartbeat.

The researchers said assessment of abdominal obesity using waist-to-height ratios may help stratify women who are likely to benefit from targeted, network-based interventions rather than isolated symptom management.

Christmas said: “Educating women early about healthy lifestyle interventions to prevent midlife weight gain is key to improving mental and physical well-being during a tumultuous time frame.”

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Perimenopause may offer “window of opportunity” for heart disease prevention

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Perimenopause may offer a key window to spot heart disease risk earlier, with women in the transition twice as likely to have low heart health scores, new research suggests.

The findings suggest the transition to menopause could be an important time to reassess risk and prompt lifestyle changes.

Garima Arora is senior author of the study and professor of medicine in the division of cardiovascular disease at the University of Alabama at Birmingham.

Arora said: “Mid-life women should think of the perimenopausal period as a ‘window of opportunity.’

They should be proactive and not wait until they reach menopause to start checking their blood pressure, cholesterol and blood sugar levels.

“Women should talk with their health care team about their reproductive status and any changes they are experiencing. It may be the perfect time to get a baseline for their heart health.”

The analysis included 9,248 women aged 18 to 80 who took part in the National Health and Nutrition Examination Survey between 2007 and 2020.

Researchers used Life’s Essential 8, a heart health score developed by the American Heart Association. It measures diet, physical activity, tobacco use, sleep, blood pressure, cholesterol, body weight and blood sugar on a 100-point scale.

Median scores fell as women moved through reproductive stages, from 73.3 out of 100 in premenopausal women to 69.1 in perimenopausal women and 63.9 in postmenopausal women.

Among the individual Life’s Essential 8 measures, diet consistently had the lowest scores and continued to decline across all reproductive stages.

After accounting for age, perimenopausal women were twice as likely to have a low overall score as premenopausal women.

They were also 76 per cent more likely to have a low cholesterol score and 83 per cent more likely to have a low blood sugar score.

The researchers said fluctuations in oestrogen levels during perimenopause may contribute to lower cardiovascular health because they may affect cholesterol, insulin resistance, blood pressure and weight management.

Insulin resistance means the body does not respond properly to insulin, the hormone that helps control blood sugar.

Sleep duration scores remained high across all reproductive stages, despite perimenopausal women reporting difficulty sleeping, suggesting sleep quality may be more affected than sleep length.

Amrita Nayak, lead author of the study and research fellow in the division of cardiovascular disease at the University of Alabama at Birmingham, said the findings highlight a point where risk may begin to rise.

She said: “Our analysis highlights that perimenopause, women’s reproductive transition period to menopause, is the critical time when the increase in cardiovascular risk seems magnified.

“When we compared women’s LE8 scores to the premenopausal baseline, the perimenopausal group was the first to show a significant jump in the odds of having low heart health.”

Arora added that nutrition could be an important area for early intervention.

“Nutrition can be a central factor for early and proactive intervention.

“Focusing on heart-healthy habits early, especially getting regular exercise and following a healthy eating plan like the DASH diet with a focus on lowering salt can help improve cardiovascular health for perimenopausal women in the years to come.”

Stacey E. Rosen, volunteer president of the American Heart Association, who was not involved in the study, said the findings underline the need to consider women-specific risk factors across life stages.

“This research highlights yet another aspect of the unique factors that increase a woman’s risk of cardiovascular disease throughout the stages of her lifespan.

“Significant health changes during pregnancy, perimenopause and menopause make it particularly important to pay close attention to increases in health risk factors during those times.

“I encourage women to talk with their primary care and specialty health care teams to learn about early detection and modification of traditional and ‘female-specific’ risk factors.

“Women can take proven steps to improve their cardiovascular health at all ages.”

The researchers said the next step is to follow women over several years to track hormone levels and heart health, which may help clarify the long-term impact of perimenopause and how lifestyle changes could reduce risk.

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