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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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Small bowel microbiome differences between women and men may help explain why some conditions are more common in women, a study suggests.
The small bowel microbiome is the community of microorganisms living in this part of the digestive tract, where they play vital roles in immune function, metabolism and hormonal regulation.
Researchers found differences between women and men in the composition and organisation of these microbial communities. One bacterial community containing Granulicatella was found only in women.
The study was conducted by investigators at Cedars-Sinai Health Sciences University.
Ruchi Mathur, director of clinical research and clinical operations for the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai and corresponding author of the study, said: “One intriguing finding was a bacterial community containing Granulicatella, which we found only in women.
“Bacteria in this community appear at increased levels in women with polyendocrine metabolic ovarian syndrome, formerly known as polycystic ovary syndrome.”
The researchers also identified differences between women and men in how microbes in the small bowel produce fructans, complex carbohydrates known to trigger digestive symptoms in irritable bowel syndrome (IBS).
IBS is far more common in women than men.
Mathur, who is also a professor of medicine, said: “Our findings show that biological sex is a critical variable in the small bowel microbiome.
“We must consider it as we move toward more personalised approaches to understanding and treating disease.”
An experimental cancer drug reduced bone loss and body fat in mice modelling post-menopausal changes, early research suggests.
The compound, CADD522, appeared to strengthen bones and help the animals stay leaner after surgery designed to mimic hormonal changes seen after menopause.
The treatment remains at an early experimental stage and has so far only been tested in animals.
The study, led by the University of East Anglia, investigated CADD522, which was originally developed to block a protein involved in the growth and spread of several cancers.
Mice treated with the compound for eight weeks showed significant improvements in bone health. Scans found increased bone volume and better preservation of the honeycomb-like structures inside bones that are crucial for strength and resilience.
Blood tests suggested the treatment stimulated new bone growth without interfering with the body’s normal process of breaking down and rebuilding bone.
Dr Darrell Green, lead researcher from UEA’s Norwich Medical School, said: “Osteoporosis affects around one in three women over the age of 50, leaving sufferers vulnerable to painful fractures that can seriously impact quality of life.
“Current treatments exist, but many are plagued by side effects, safety concerns or inconvenient dosing schedules that make long-term use difficult.”
The researchers also found that mice receiving CADD522 weighed less than untreated mice despite eating the same amount of food.
They had less body fat and fewer fat deposits in their bone marrow, a process commonly seen after menopause and linked to declining bone health.
The team also examined brain tissue and found that the drug appeared to reverse several menopause-related changes in fatty acids.
Levels of omega-3 fats including DHA remained largely intact, while several other lipid abnormalities shifted back towards healthier patterns.
Green said: “We didn’t directly test for memory or thinking ability, but our work raises questions about whether this drug could one day help address wider menopause-related health problems.”
Safety experiments in mice, rats and dogs found that CADD522 could be taken orally and was well tolerated.
The compound also appeared to be metabolised more slowly in human tissue than in rodents, potentially improving its performance in people.
“This is still in the early stages and has so far only been tested in animals but we hope that the benefits will translate to humans to ultimately reduce fracture rates,” added Green.
The research was led by UEA in collaboration with the University of Maryland, the Scintillon Research Institute in San Diego and the University of Stirling.
Safety testing was funded by The Sir William Coxen Trust as part of the development of CADD522 as a childhood cancer treatment.
Weight loss surgery was linked to more regular periods and fewer polyendocrine metabolic ovarian syndrome (PMOS) symptoms in women aged 18 to 45 living with obesity in a recent study.
The researchers recommend that women undergoing the procedure have access to preconception care and reproductive counselling to support their reproductive health.
Researchers at the University of Surrey analysed data over 24 months from 84 women who underwent bariatric surgery and 18 women living with obesity who did not have surgery.
Of those who underwent surgery, 49 had gastric bypass procedures and 35 had gastric sleeve surgery.
Women who underwent metabolic bariatric surgery lost more than 30kg on average at 12 and 24 months after the procedure.
Among women with polycystic ovaries, the condition persisted in only 10 per cent after 24 months.
Women also reported a resolution of clinical hirsutism, or excess body hair, by 12 months.
Women who had previously experienced irregular periods reported more regular menstrual cycles after surgery.
Professor Martin Whyte, co-author of the study and professor of metabolic medicine at the University of Surrey, said: “A large proportion of those undergoing bariatric surgery are women of reproductive age, who may be planning a pregnancy in the coming years.
“So much remains unknown about the impact of this type of surgery on women who are planning to have children.
“This raises the question of when the ideal time after surgery is to conceive.”
Women have a higher prevalence of obesity than men, with 57 per cent of women in the UK classified as overweight and 27 per cent living with obesity, which can affect fertility and the health of an unborn baby.
The researchers said 17 women had healthy pregnancies following surgery.
Although this was not specifically examined in the study, no difference in birth weight was observed between babies conceived within or after the first year.
Dr Kathryn Hart, co-author of the study and associate professor in nutrition and dietetics at the University of Surrey, said: “What we have found is that bariatric surgery positively affects the reproductive health of women living with obesity and can improve the likelihood of them having a healthy pregnancy after surgery.
“Dysregulated hormone levels, irregular periods and conditions such as polycystic ovaries are affected by obesity.
“By reducing this, what we have seen is that it can lead to improvements without the need for medication.
“We would suggest that clinicians consider medical intervention for obesity to treat irregularities in the menstrual cycle and issues with fertility.”
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