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Study shows Leva device helps women to reduce urinary incontinence

This is the first study to demonstrate the superiority of digital therapeutic devices over Kegels alone in treating urinary incontinence.

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Leva

Renovia has announced the results of a trial comparing their Leva pelvic floor device to Kegel exercises for women with urinary incontinence.

Renovia is a female-led company focused on pelvic floor disorders. It announced the results of a randomised, controlled trial that revealed pelvic floor muscle training (PFMT) using their Leva Pelvic Health System is clinically superior to Kegels alone for improving stress and stress-dominant mixed urinary incontinence in women.

Leva is an FDA-approved digital therapeutic device that combines a small vagina motion sensor with a smartphone app to offer non-invasive, drug-free ways for women to strengthen their pelvic floor muscles. Leva requires just five minutes of practice per day which can be done at home at any time.

This is the first study to demonstrate the superiority of digital therapeutic devices over Kegels alone in treating urinary incontinence. The women who used Leva to guide their PFMT exercises achieved significantly improved UI symptoms and a reduction of episodes in comparison to those who did not.

The study enrolled 363 patients, who reported benefits such as a reduction in leakage episodes decrease from almost two leaks per day to only one leak every three days. Patients reported superior symptom improvements in stress UI and stress-dominant mixed UI, compared with those in the Kegels-only control arm at eight weeks.

A significantly greater number of women in the leva group reported they were “much improved” or “very much improved” on the Patient Global Impression of Improvement scale.

Leva study

A recently published US study shows that 62 per cent of women are affected by urinary incontinence. However, the study also revealed that only 25 per cent of women do Kegels correctly which could limit the effects of UI symptoms.

Milena M. Weinstein, MD one of the study’s principal investigators said: “78 million American women experience UI, and this number is expected to continue increasing. UI can have serious emotional and physical repercussions, which is why new strategies for delivering effective treatment to women are essential.

This study suggests digital health, particularly tools that keep clinicians involved in patient care, could play a valuable role by expanding treatment access to a larger group of women and—equally important—actively supporting their success.”

Milena M. Weinstein, MD said: “Multiple studies show that pelvic floor muscle training can offer effective, first-line treatment for urinary incontinence. This study demonstrated the efficacy and safety of leva, a motion-based digital therapeutic device that guides pelvic floor muscle training – with the women in the leva group achieving superior improvements in stress and stress-dominant mixed urinary incontinence.

Significantly, the leva device could make first-line therapy more accessible by offering a new opportunity for obstetrician-gynaecologists to monitor and engage with women to support their success with first-line treatment.”

Eileen Maus, CEO of Renovia commented: “UI is not a normal part of ageing, and women deserve better than a lifetime of adult diapers and pads. Prescription digital therapeutics like leva offers a novel way for women and their clinicians to work together to make first-line UI treatment both successful and accessible.

As the prevalence of UI continues to increase, this randomized controlled trial—a first-of-its-kind for a digital therapeutic for UI—shows leva can help clinicians reach more of the 78 million women experiencing bladder leaks and demonstrated the power and promise of remotely conducted clinical trials in medical research.”

Read more: Female health focused brands report experiencing censorship online

Pregnancy

Women should not be pressured into an ‘ideal birth’, says health secretary

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Women should not feel pressured into an “ideal birth”, health secretary Yvette Cooper has said as she promised major maternity reform.

Cooper has returned to the Department of Health and Social Care 27 years after serving as public health minister under Tony Blair.

She said maternity and child health would be a major focus of her new role, alongside significant reforms to social care.

In an interview with the Guardian, Cooper said the changes should address any pressure on women to pursue a particular birth experience.

Families affected by maternity failures have repeatedly raised concerns that some units were reluctant to escalate medical interventions because of a preference for more natural births.

Cooper said: “I would worry about any mum feeling pressurised that there is somehow a kind of an ideal birth experience to live up to when it’s always different in every case, and you have to follow the evidence, you have to have informed choice.”

As one of her first actions as health secretary, Cooper said she intended to reintroduce binding national maternity standards.

The standards were dismantled during early Conservative NHS reforms and replaced with fragmented arrangements managed separately by individual hospital trusts.

A new maternity taskforce will draft the standards, which will have five central aims.

These include ending regional differences in levels of care and tackling racial inequalities linked to poorer outcomes in deprived areas, particularly for Black and Asian women.

Patient experiences will also form part of how standards are measured, while new targets will aim to identify underperformance before a major scandal develops.

Cooper, who became the first minister to take maternity leave while serving as a junior health minister in the early 2000s, said reports into maternity scandals had been “traumatic” to read and showed that systemic change was needed.

She said: “We’ve always said the NHS is about the cradle to the grave. I want to make it a personal crusade to put the cradle back at the heart of the NHS, and to have much more focus around maternity and child health, the very beginning of a family’s life, making that much more central to the priorities of the NHS, giving it the priority that it really deserves.”

Cooper said discussions about how maternity services could better listen to mothers’ needs had been taking place for the past two decades.

However, she said the emphasis on placing women and families at the centre of care appeared to have been lost.

She said: “It feels incomprehensible that we could be in this situation in the 2020s. I went back to look at some of the things that we’d done 25 years ago.

“And what did strike me was how much we were talking then about women and families being at the centre of care and about listening to women’s views.

“It is really shocking and distressing feeling that has somehow been lost in some of the maternity units where actually it should be the central issue.

“I had a direct interest. I was pregnant at the time. But I am really struck by it now, just feeling like there is this big gap in the priorities that the NHS has been focused on.”

Cooper said she was determined to provide a robust response to Donna Ockenden’s investigations into maternity failures at Shrewsbury and Telford and Nottingham, alongside Baroness Valerie Amos’s national investigation into England’s maternity system.

The investigations highlighted systemic clinical errors, understaffing and toxic institutional cultures. They found that hundreds of infant and maternal deaths were directly linked to failures to listen to mothers and defensive attempts to protect institutions.

Amos’s review faced criticism, including the resignation of an expert adviser over the lack of explicit warnings about “normal birth ideology”.

Families also questioned whether the review’s proposed statutory maternity commissioner would have sufficient independence.

Cooper said she remained committed to introducing the role.

She said: “In the end, the most important people in the maternity services are the mothers, babies, the families. But the point of having a maternity commissioner is to make sure that those issues are championed as part of an NHS.”

She also said reforms needed to address an oppositional culture between doctors and midwives in some trusts over when medical intervention during birth may be necessary.

Cooper said: “The thing that struck me most was the sense of women feeling they weren’t being listened to … And I think that probably does go back to issues around culture.”

Cooper, who served as foreign secretary until recently, said she was prepared for a difficult period in the health role as she sought to implement Andy Burnham’s social care reforms.

She said she remained committed to establishing the national care service announced by the prime minister the previous week.

A longstanding ally of former prime minister Keir Starmer and a former rival of Burnham in the 2015 Labour leadership contest, Cooper said she believed the change of prime minister had been necessary.

She said: “Of course it’s not easy. I really did not think it was possible to win the election when I came back into the shadow cabinet in 2022. It’s only because of what Keir did that we managed to win.

“But we had very difficult local election results … we have to respond to that. But I think we’ve got a sense of energy now.

“All of the things that Andy wants to focus on and drive are also just very much the things that that people are concerned about across the country.”

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Motherhood

One in eight mothers diagnosed with gestational diabetes, research finds

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One in eight mothers in England is now diagnosed with gestational diabetes, after diagnoses of the condition rose by 60 per cent in just five years, according to a major study.

The research found that rates of gestational diabetes increased from around 8 per cent of pregnancies in 2018 to more than 12 per cent in 2022.

Gestational diabetes mellitus (GDM) develops when the body cannot produce enough insulin to regulate blood sugar levels during pregnancy.

It is the most common complication to occur during pregnancy and is associated with a heightened risk of preterm birth, emergency caesarean section, and babies being born either larger or smaller than expected for their gestational age.

The condition is also linked to longer-term health risks for both mothers and their children.

Laura Magee is professor of women’s health at King’s College London and co-investigator on the study.

She said: “Pregnancy outcomes for women with gestational diabetes are still worse than those for women without gestational diabetes.

“Further work is required to address how control of blood sugar and timed birth can address the excess of adverse pregnancy outcomes, compared with the general maternity population.

“Follow-up after birth is also essential, as women with prior gestational diabetes are at increased risk of cardiometabolic disease, including type 2 diabetes mellitus, but also high blood pressure and elevated blood cholesterol, starting within the first year after birth.”

For the study, researchers analysed routinely collected NHS maternity data covering more than 2.3 million mothers and around 2.8 million births across 184 hospitals in England between 2018 and 2022, making it one of the largest investigations of its kind.

The study uncovered marked inequalities in both the prevalence of gestational diabetes and pregnancy outcomes more broadly.

The sharpest rises in diagnoses were recorded among Asian women, among whom rates reached around 23 per cent, and among women living in the most deprived areas, where rates climbed to about 14 per cent.

The disparities extended beyond gestational diabetes.

Black mothers were found to be more likely to experience an emergency caesarean birth, women in deprived areas were more likely to give birth prematurely, and Asian mothers were more likely to have babies born small for their gestational age.

Among these higher-risk groups, researchers found that a diagnosis of gestational diabetes further compounded the risk of preterm birth.

Rising maternal age, increasing rates of obesity and improvements in how data is captured by the NHS are all likely to be contributing to the growing prevalence of the condition, the researchers said.

Notably, they found that changes to gestational diabetes screening introduced during the Covid-19 pandemic did not meaningfully affect the overall upward trend in diagnoses, suggesting the rise reflects genuine underlying changes in the population rather than shifts in testing practice.

The researchers said the findings pointed to an urgent need to strengthen maternity services and improve support for the women at greatest risk.

Experts said the findings also carried implications that extend well beyond pregnancy itself.

Dr Sonya Babu-Narayan, clinical director at the British Heart Foundation, said the study was part of a wider pattern of research using large-scale health data to uncover hidden risks.

“Big data research studies like this, which can now analyse millions of healthcare records, are uncovering a concerning rise in conditions which raise people’s chances of having a future heart attack or stroke,” she said.

“Gestational diabetes often goes away after pregnancy, but it can increase women’s risk of future cardiovascular disease.”

Dr Babu-Narayan called on healthcare professionals to routinely ask women about pregnancy-related risk factors, regardless of how long ago the pregnancy took place.

“Healthcare professionals who want to fully understand people’s risk of heart attack and stroke should routinely ask women about risk factors unique to them, such as diabetes or high blood pressure in pregnancy – even if that pregnancy was decades earlier,” she said.

“If you are a woman who has had diabetes or high blood pressure during pregnancy, it is especially important to attend health checks when invited.”

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New tool identifies heart disease risk in women earlier in life

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Researchers in the US have developed a new tool designed to identify women at risk of heart disease much earlier than existing methods allow.

The findings, published in the journal JACC: Advances, highlight significant gaps in the risk assessment approaches currently used in clinical practice.

“Heart disease is the leading cause of death in women, yet existing risk tools were developed in older populations and ignore factors unique to women,” said senior author Robert Platt, professor in the Department of Epidemiology, Biostatistics, and Occupational Health and director of the School of Population and Global Health.

He noted that while pregnancy complications are known to be linked to future heart risk, there has until now been no reliable way of identifying which younger women are most at risk.

To build the tool, researchers analysed health data from more than 260,000 women in the UK aged between 15 and 45 who had given birth.

The team developed and validated a prediction model to estimate future heart disease risk, following participants for nearly four years after delivery.

The model identified several factors not included in existing risk tools that can help predict a woman’s likelihood of developing heart disease.

These include hypertensive disorders of pregnancy, gestational diabetes, preterm birth, polycystic ovary syndrome (PCOS), depression, thyroid disorders, oral contraceptive use and social deprivation.

The findings suggest that some women, particularly younger women often dismissed as low risk, may in fact face a higher risk of heart disease earlier than previously recognised.

“Millions of women who give birth each year are never considered candidates for cardiovascular risk assessment simply because of their age,” said co-author Kristian Filion, professor in the Departments of Medicine and of Epidemiology, Biostatistics, and Occupational Health.

He added that if integrated into routine postpartum care, the tool could enable earlier monitoring, lifestyle counselling or referral to a specialist, potentially helping to prevent a heart attack or stroke later in life.

The research team’s next step is to validate the model using data from Canada and the United States.

In the longer term, they hope to integrate a practical calculator into electronic health records, allowing higher-risk patients to be identified and supported earlier.

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