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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.
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.”
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Transdermal HRT best protects bone density in women with functional hypothalamic amenorrhoea, a condition that stops periods, a review of trials has found.
The meta-analysis pooled randomised clinical trials involving 692 participants and found transdermal hormone replacement therapy and teriparatide increased bone mineral density by between 2 and 13 per cent.
Functional hypothalamic amenorrhoea can follow anorexia or intense exercise. Bone mineral density measures bone strength and the amount of mineral in bone.
Around half of women with the condition have low bone mineral density, compared with about 1 per cent of healthy women, and their fracture risk is up to seven times higher.
The research was conducted by scientists at Imperial College London and Imperial College Healthcare NHS Trust.
Professor Alexander Comninos, senior author of the study and consultant endocrinologist at the trust, said: “Bone density is lost very rapidly in FHA and so addressing bone health early is very important to reduce the lifelong risk of fractures.
“Our study provides much needed comparisons of all the available treatments from all available studies.
“Clearly the best treatment is to restore normal menstrual cycles and therefore oestrogen levels through various psychological, nutritional or exercise interventions – but that is not always possible.
“The foundation for bone health is good calcium and vitamin D intake (through diet and/or supplements) but we have additional treatments that are more effective.”
When FHA is diagnosed, clinicians first try to restore periods through lifestyle measures, including psychological and dietary support, but these can fail. Guidelines then recommend giving oestrogen, though the best form was unclear.
The team reviewed all prior randomised trials comparing therapies, including oral and transdermal oestrogen, and also assessed teriparatide, a prescription bone-building drug used for severe osteoporosis.
They found no significant benefit for oral contraceptive pills or oral hormone therapy.
A recent UK audit reported that about a quarter of women with anorexia-related FHA are prescribed the oral contraceptive pill for bone loss; the study suggests using transdermal therapy instead.
Comninos said: “Our goal is simple: to help women receive the right treatment sooner and to protect their bone health in the long-term.
“We hope this study provides clinicians with better evidence to choose transdermal oestrogen when prescribing oestrogen and so inform future practice guidelines.
“Right now, millions of women with FHA may not be receiving the best treatments for their bone health.”
An AI tool cut interval breast cancers by 12 per cent in a Swedish screening trial of more than 105,000 women.
The study also found 27 per cent fewer aggressive breast cancers detected at screening when AI was used.
Interval cancers are cancers found between routine screening appointments because they were missed at the original scan. They are often more dangerous and linked to higher death rates than cancers found at screening.
The MASAI trial is described as the first large randomised study to test whether AI can improve mammography screening, which uses low-dose X-rays to examine breast tissue for signs of cancer.
The AI tool, called Transpara Detection and developed by ScreenPoint Medical, supported radiologists in analysing mammography images.
Earlier results from the same trial showed that Transpara Detection increased cancers found by 29 per cent and reduced radiologist workload by 44 per cent compared with standard double-reading, where two radiologists independently review each scan.
The latest findings indicate higher accuracy with AI support. Sensitivity, the ability to detect cancer, was 6.7 percentage points higher in the AI group while specificity, the ability to rule out healthy cases, was maintained. Results were similar across age groups and breast density levels.
Women screened with AI had 16 per cent fewer invasive interval cancers and 21 per cent fewer large interval cancers than those in the standard screening group.
The system also helps doctors assess risk more precisely by subdividing suspicious findings into BI-RADS 4 categories A, B and C. BI-RADS (Breast Imaging Reporting and Data System) is a standardised scale that guides whether a patient needs closer monitoring, further tests or treatment.
Ageing anxiety may accelerate biological ageing in women, with fears about worsening health linked to faster epigenetic ageing, according to new research.
The study found that greater anxiety about growing old was associated with accelerated epigenetic ageing, as measured by the DunedinPACE clock, based on biological markers in blood samples.
Epigenetic changes are shifts in how genes are switched on or off without altering DNA itself, which can influence how the body ages and functions.
“Our research suggests that subjective experiences may be driving objective measures of ageing,” said Mariana Rodrigues, a PhD student and the first author of the study.
“Ageing-related anxiety is not merely a psychological concern, but may leave a mark on the body with real health consequences.”
Researchers analysed data from 726 women in the Midlife in the US study.
Participants were asked how much they worried about becoming less attractive with age, having more health issues and being too old to have children.
Blood samples were used to assess ageing with two epigenetic clocks: DunedinPACE, which estimates the pace of biological ageing, and GrimAge2, which estimates cumulative biological damage.
The study was conducted by researchers at NYU School of Global Public Health.
Worrying about declining health showed the strongest links with epigenetic ageing, while anxiety about attractiveness and fertility was not significantly associated with biological markers.
The authors suggest health worries are more common and persist over time, whereas concerns about appearance and reproduction may fade with age.
“Women in midlife may also be multiple in roles, including caring for their ageing parents,” Rodrigues said.
“As they see older family members grow older and become sick, they may worry about whether the same thing will happen to them.”
The authors caution that the study offers a snapshot in time and other factors may influence these biological changes.
When analyses were adjusted for health behaviours such as smoking and alcohol use, the link between ageing anxiety and epigenetic ageing decreased and was no longer significant.
“Our research identifies ageing anxiety as a measurable and modifiable psychological determinant that seems to be shaping ageing biology,” said Adolfo Cuevas, associate professor of social and behavioural sciences and the study’s senior author.
They call for more research to clarify how this anxiety influences ageing over time, to guide support for those experiencing ageing anxiety.
“Ageing is a universal experience.” Rodrigues said.
“We need to start a discourse about how we as a society, through our norms, structural factors and interpersonal relationships, address the challenges of ageing.”
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