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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

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Lawyers warn of discrimination risks around lack of menstrual health support in the workplace

Employers should consider proactively supporting women in managing menstruation at work, lawyers have argued

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Employers should consider the potential discrimination risks around menstrual health in the workplace, lawyers have warned, as research shows that most women in the UK feel unsupported.

According to the Chartered Institute of Personnel and Development (CIPD), the majority of women in the UK do not feel a strong sense of support in their organisation in relation to their menstrual cycle.

Figures show women are more likely to feel supported by colleagues than by their employer or manager, with only one in 10 reporting that their organisation provides support for menstruation and menstrual health.

Annisa Khan, employment lawyer at Farrer & Co who has previously raised the alarm over the lack of practical measures to support women with their periods, told Femtech World that employers should be mindful of the legal risks related to managing menstruation.

“Under the Equality Act 2010, it is unlawful to discriminate against employees based on sex, age, or disability,” she said.

“Employers should therefore consider the potential discrimination risks in relation to managing mensuration in the workplace and implement measures to reduce these risks.”

A lack of workplace period policies has been estimated to cost businesses over £6bn per year, as menstrual symptoms cause women to miss an average of 8.4 days per year due to lower productivity.

Khan said organisations should consider proactively supporting employees in managing menstruation at work by reviewing existing policies, including sickness absence and health and wellbeing policies, to ensure they effectively address menstrual-related concerns.

“Creating an open and supportive environment is crucial for employees to feel comfortable discussing periods at work,” she explained.

“This involves raising awareness among all staff, including senior-level managers and male colleagues, to foster an understanding of how colleagues may be affected by menstruation, the relevant policies and how to have open and empathetic conversations.

“Implementing practical measures is also essential to create a supportive environment. Practical steps can include having accessible bathroom facilities with sanitary bins, providing free period products to employees, offering additional breaks and providing a quiet space for rest.”

In line with CIPD’s findings, Khan said workplaces should also consider implementing more flexible working practices and giving women more breaks when needed.

“Employers should be open to employees adjusting their work pattern on the days they are experiencing menstruation symptoms by, for example, offering employees the opportunity to work from home.

“Additionally, they should consider the needs of employees with disabilities or those with medical conditions, and how they may be affected by managing mensuration at work.”

Heidi Watson, employment partner at Clyde & Co, said employers should ensure they avoid breaching discrimination laws when approaching issues like menstrual health.

“As awareness of menstrual issues such as endometriosis grows and as employees are more willing to discuss their symptoms at work, employers will need to consider whether employees are disabled under the legal definition and therefore entitled to protection from less favourable treatment and subject to the duty of the employer to make reasonable adjustments for them,” she told Femtech World.

“Employees may also be able to establish sex or age discrimination claims. We can expect more claims to come before the Employment Tribunal in the not too distant future, in a similar way as we have seen with cases involving menopause in recent years.

“Adopting a flexible approach to managing those with menstrual symptoms which are impacting their work, and creating an open and supportive culture around the issue, will help to reduce the risk of such claims being brought,” she added.

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OB/GYN-founded vitamin company pledges US$10m to improve women’s health research

Perelel aims to close the divide on women’s reproductive health research and improve access to nutritional support

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Alex Taylor and Victoria Thain Gioia, co-founders of Perelel

The US OB/GYN-founded vitamin company Perelel has pledged US$10m to Magee-Womens Research Institute and Good+ Foundation to fund women’s health research and address gaps in maternal healthcare.

The vitamin company said the US$10m would be distributed as both in-kind product donations and funding grants through 2027 focused on advancing women’s reproductive health.

Magee-Womens Research Institute is the largest US research foundation focused exclusively on women’s health, reproductive biology and infant research and care.

Good+Foundation is a national nonprofit working to dismantle multi-generational poverty by pairing tangible goods with innovative services for under-resourced individuals.

“As the only female OB/GYN-founded women’s vitamin company, Perelel is committed to ensuring that all women have access to medically backed care,” said Victoria Thain Gioia, co-founder and co-CEO of Perelel.

“This is why we are devoted to furthering women’s research in partnership with Magee-Womens Research Institute and creating more equity in the way underserved communities receive critical prenatal micronutrients that would otherwise be inaccessible thanks to Good+Foundation.”

Research shows that medical studies have historically excluded female participants and data have been collected from males and generalised to females.

The exclusion of women of “childbearing potential” from clinical research studies has meant that women’s diseases are often missed, misdiagnosed or remain a total mystery.

Alex Taylor, co-founder and co-CEO and of Perelel, said: “We recognise how wildly complex women’s bodies are — bodies that have historically been oversimplified, objectified and shamefully under-researched in medicine.

“Unfortunately, it’s not as simple as ’12 essential nutrients.’ In founding Perelel, we hope to shine a light on how dynamic our bodies are by supporting them with targeted solutions made by the doctors and experts who know best.

“Core to what we stand for is the need to keep fighting for our fundamental rights and help close the women’s health research gap and improve body literacy.”

Perelel’s pledge comes at a time of intensified focus on women’s health as efforts start to reach new levels, including the White House, after President Joe Biden announced the first-ever initiative on Women’s Health Research in 2023.

“It is critical that there is more in-depth medical research done to support women at every hormonal life stage,” said Michael Annichine, CEO at Magee-Womens Research Institute and Foundation.

“Perelel has committed to a cash donation to further advance research into women’s reproductive health and to ensure that this research is made more accessible to doctors everywhere.”

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New treatment could ‘disrupt’ growth of breast cancer tumours

A new type of immunotherapy could lead to pioneering treatment for breast cancer

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A breakthrough injection could “disrupt” the growth of breast cancer tumours, paving the way for a pioneering new treatment.

Breast cancer is the most common cancer in the UK with one woman diagnosed every 10 minutes. Around 55,000 women in the UK are diagnosed with breast cancer every year and 11,500 die from the disease each year.

Researchers from the Institute of Cancer Research have found that a new type of immunotherapy that targets non-cancer cells could help prevent the growth and spread of breast cancer tumours.

The discovery, published in The Journal for ImmunoTherapy of Cancer, has found that an immunotherapy approach targeting a protein, called endosialin, disrupts the tumour’s blood supply and, as a result, can hinder its growth and spread.

Unlike most cancer treatments, this innovative treatment does not target cancer cells directly but attacks the cells that support the disease instead.

Researchers used a type of immunotherapy called CAR-T therapy, which involves removing a patient’s healthy immune cells and genetically modifying them to attack specific targets.

CAR-T therapies are already being used to treat some blood cancers, and scientists are trying to find ways to make them effective for other types of cancer, including breast cancer.

However, CAR-T cell therapy does not always work on tumours because their environment suppresses the immune response, and it can also be challenging to find specific features on the breast cancer cells to target.

To work around these challenges, the team directed the CAR-T cells to cells surrounding the tumour’s blood supply that make the endosialin protein, rather than actual cancer cells. In experiments in mice, scientists found that targeting endosialin successfully reduced the breast cancer’s growth and spread.

The team, based at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research (ICR), also tested the treatment on lung cancer tumours in mice and saw similarly successful results, suggesting patients with other types of cancer could benefit from this new treatment too.

In addition, researchers found that the CAR-T therapy did not affect cells without endosialin, indicating this could work as a cancer-specific treatment with potentially fewer side effects for patients.

“This is the very first study that demonstrates the effectiveness of using endosialin-directed CAR-T cells to reduce breast cancer tumour growth and spread,” said Dr Frances Turrell, study co-leader and postdoctoral training fellow in the division of breast cancer research at the Institute of Cancer Research.

“Immunotherapy has had limited success in treating breast cancer but by targeting the cells that support the tumour and help it to survive, rather than the cancer cells directly, we’ve found a promising way to overcome the challenges posed by the tumour environment and develop a more effective and targeted treatment for breast cancer.

“We could not have done this project without funding to the Molecular Cell Biology group from Breast Cancer Now and we hope that further research will help translate these findings into targeted therapies for breast cancer patients.”

Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: “This exciting research could lead to much-needed targeted treatments for people with breast cancer, and with one person dying from breast cancer every 45 minutes in the UK, new treatments like these are urgently needed.

“Now we know that the treatment works in principle in mice, Breast Cancer Now researchers can continue to develop this immunotherapy to make it suitable for people, as well as to understand the full effect it could have and who it may benefit the most.”

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