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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.”

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Don’t miss HTW’s upcoming deep dive into health AI

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Our sister publication Health Tech World brings its first live event to London this summer, gathering the people building, buying and regulating healthcare AI for a single afternoon. With a full line-up confirmed and two months to go, tickets are open now, and this first edition is one to book early.

Health Tech World Live, the debut live event from FemTech World’s sister title Health Tech World, makes its first appearance on Friday 21 August, bringing clinicians, founders, developers, NHS commissioners and investors together at Teesside University London in Stratford for an afternoon on where healthcare AI goes next. The programme is confirmed, and with two months to go, it is worth booking your place while the diary is still clear.

The line-up for this first edition reads like a who’s-who of UK health AI. Speakers include Dr James Harmsworth King, Chief Medical Strategy Officer at Numan, fresh from the MHRA’s AI Airlock; Dr Sonia Szamocki, founder and CEO of 01Health; Hugo Dragonetti of NHS London Procurement Partnership; Mikael Kågebäck, CTO at Sleep Cycle; Max Gattlin, Commercial Director at X-on Health; and Marcus Vass, Head of Digital Health at Osborne Clarke, with proceedings chaired by Alastair MacColl.

Across six sessions, the afternoon moves from scaling specialist care and smarter NHS procurement, through responsible delivery and consumer AI, to fair access to GP care and the regulation underpinning all of it. Between the talks, delegates get time with the speakers and the Health Tech World editorial team, the kind of access that is hard to come by anywhere else.

It is shaping up to be one of the summer’s standout dates in health tech, and a launch worth being part of from the start. If you are planning to be there, now is the time to get it booked.

The future of healthcare AI: strategies, opportunities and vital insights
When: Friday 21 August 2026, 12 noon to 4pm
Where: Teesside University London Campus, Queen Elizabeth Olympic Park, 14 East Bay Lane, London, E15 2GW
Tickets: £99

Book your place now »

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Immunotherapy may temporarily restore fertility in premature menopause

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Immunotherapy may temporarily restore fertility in women with autoimmune premature ovarian insufficiency, a pilot study suggests.

Three of the 10 women who received treatment later gave birth to healthy babies.

Premature ovarian insufficiency, or POI, affects just over three per cent of women worldwide and occurs when the ovaries stop functioning before the age of 40.

The condition significantly reduces fertility and can have several causes, including autoimmune processes and genetics.

Researchers at Karolinska Institutet examined whether immunotherapy could make the ovaries temporarily responsive to hormonal stimulation in women with POI caused by autoimmunity.

The study included 12 women aged between 18 and 35 with autoimmune POI.

Two withdrew before treatment began. The remaining 10 underwent ovarian hormone stimulation before receiving rituximab and again four to six months after treatment.

Rituximab is an approved and well-established medicine used to treat several autoimmune conditions and cancers.

None of the women responded to ovarian stimulation before receiving the drug.

After treatment, six developed follicles that made it possible to retrieve eggs in response to ovarian stimulation.

Follicles are small sacs within the ovaries where eggs develop.

Professor Angelica Lindén Hirschberg, the study’s first author and a professor at Karolinska Institutet’s Department of Women’s and Children’s Health, said: “The results show that in some women there remains an egg reserve that can be activated when the autoimmune process is suppressed.”

In five women, mature eggs could be frozen or fertilised.

Three later had embryos transferred and all three gave birth to healthy babies.

For safety reasons, the embryo transfers took place no earlier than one year after treatment.

One serious side effect was reported and was linked to the hormone stimulation rather than the immunotherapy.

Women with autoimmune POI commonly have other autoimmune diseases.

All six women who responded to the treatment also had autoimmune Addison’s disease, a condition in which the immune system destroys the adrenal glands.

The study was a proof-of-concept investigation without a control group and involved a small number of participants, meaning the findings must be interpreted cautiously.

A proof-of-concept study is an early investigation designed to assess whether an approach could work before it is tested more widely.

Professor Lindén Hirschberg said: “This is a first step. To determine whether the method is effective and safe, larger, randomised studies are required.”

The research team has launched a larger randomised study.

The work was carried out by researchers at Karolinska Institutet, Karolinska University Hospital and the University of Bergen.

It was funded by organisations including the Swedish Research Council, the Knut and Alice Wallenberg Foundation, the Novo Nordisk Foundation and Region Stockholm.

The researchers reported no conflicts of interest.

POI is also linked to long-term health risks caused by oestrogen deficiency, including osteoporosis, an increased risk of cardiovascular disease, cognitive decline and poorer mental and sexual wellbeing.

Hormone replacement therapy can relieve menopausal symptoms and reduce many of these risks, but no treatment has been reliably shown to restore fertility in women with POI.

Egg donation was previously the only option for women with the condition who wanted to become pregnant.

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Xella launches AI-powered precision health platform

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Xella Health has launched what it calls the first AI precision health platform built for the XX chromosome.

The company says it aims to address a lack of diagnostic precision and clinical research focused on female biology.

Women make up half of the population and account for 80 per cent of consumer healthcare decisions, but research into women’s health has historically received less funding than male-focused studies.

Kelly Lacob, Xella Health co-founder and chief executive, said: “Women have been trapped in a diagnostic dark age experiencing debilitating symptoms like severe period pain, bloating and GI issues, exhaustion, and brain fog, routinely dismissed by the healthcare system.

“This dismissal results in women being diagnosed four years later than men, on average, for the same conditions, and a seven-to-10-year delay for women to receive an accurate diagnosis for conditions like endometriosis.

Stalling necessary care and treatment results in prolonged suffering with chronic pain, heightened infertility risks, and declining mental health.

Xella is here to replace the systemic medical gaslighting women have endured for generations.

We are handing women the evidence and information they need to advocate for themselves and secure faster, accurate diagnoses before early-stage conditions spiral.”

Xella says its AI examines billions of data points from clinical information and multi-omic biomarkers to assess the probability of more than 130 conditions specific to female biology.

Multi-omic data combines information from several biological areas, including genes, proteins and hormones.

The conditions assessed include polyendocrine metabolic ovarian syndrome, or PMOS, formerly known as polycystic ovary syndrome, as well as perimenopause and endometriosis.

Xella was founded by Lacob, Adriana Dantas and Dr Jesus Ching, who developed the concept while working together on molecular diagnostics at Mammoth Biosciences.

The founders say the platform is designed to provide information about possible underlying causes through advanced testing and long-term care of a kind often available only through expensive concierge services.

They drew on personal experiences to build a service intended to identify small changes in a woman’s biological baseline.

Members complete an initial health questionnaire before having blood taken at a local partner laboratory such as Quest or Labcorp.

A phlebotomist can also visit a member’s home for an additional charge.

The company’s AI analyses biomarker data from genomics, proteins and hormones alongside symptoms, lifestyle risks and medical history.

Xella says this information is used to screen for more than 130 female-specific conditions, including PMOS, Hashimoto’s disease, premenstrual dysphoric disorder, endometriosis and perimenopause timelines.

Hashimoto’s disease is an autoimmune condition in which the immune system attacks the thyroid gland.

Premenstrual dysphoric disorder, or PMDD, is a severe form of premenstrual syndrome that can cause significant emotional and physical symptoms.

The results are processed through Xella’s own dry laboratory, which the company says is certified under the US Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists.

A dry laboratory analyses data using computing and other non-experimental methods rather than carrying out traditional laboratory procedures.

The findings are turned into a personalised healthcare plan and reviewed with a certified telehealth doctor.

The doctor may recommend immediate clinical action, including personalised hormone therapy or referrals to genetic counsellors, pelvic floor physiotherapists and reproductive endocrinologists.

Reproductive endocrinologists are doctors who specialise in hormones, fertility and reproductive health conditions.

Dantas, co-founder and chief operating officer, said: “Women’s health data has historically been treated in isolated silos – a hormone test here, an ultrasound there – but no one was connecting the dots across the entire biology.

“By tracking unique biological patterns longitudinally across cycles and life stages, we aren’t just providing data, but a clear path forward.”

Xella’s clinical advisers include Dr Allison Kurian, director of Stanford Women’s Clinical Cancer Genetics Program and professor of medicine, epidemiology and population health at Stanford.

They also include Dr Lynn Westphal, a reproductive endocrinology and infertility specialist and chief medical officer of Kindbody.

Xella has received US$4.7m in angel and pre-seed funding from Precursor Ventures, Capital F, Ulu Ventures and Swizzle Ventures.

Other funds and angel investors from healthcare, diagnostics and consumer technology also participated.

Margaret Coblentz, co-founder and general partner of Capital F, said: “Women’s health is one of the highest-momentum categories in the market today, driven by a US$15tn female economy.

“Xella represents exactly how Capital F sees women’s health evolving: deep clinical expertise paired with a consumer-first mindset, and a genuine opportunity to unlock the next generation of healthcare.”

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