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US clinical trial to evaluate digital therapeutic for overactive bladder
Amara Therapeutics has announced the launch of a randomised controlled trial evaluating the efficacy and safety of its prescription digital therapeutic (PDTx) for the treatment of overactive bladder (OAB) in women.
OAB is a prevalent condition that significantly impacts the quality of life for millions of women, with symptoms such as urinary urgency, urinary frequency, nocturia, and urgency urinary incontinence (UUI).
The APPROVE Trial aims to assess changes in OAB symptoms and quality of life, comparing OAB treatment with the RiSolve App versus standard behavioral education in women with OAB.
The APPROVE Trial will also evaluate treatment satisfaction.
The trial is being recruited virtually and will randomise close to 600 participants at 10 centres, and recruit women across the United States.
The APPROVE Trial is backed by The Foundation for Female Health Awareness, which is a non-for-profit, 501(c)(3), organisation committed to advancing research and improving treatment options for female pelvic floor conditions.
Dr Mickey Karram is co-founder and CEO of the foundation.
Karram said: “Our mission is to support innovative research that enhances the well-being of women.
“RiSolve represents a promising new avenue in digital medicine, and we look forward to the insights this trial will provide.”
RiSolve, developed by Amara Therapeutics, is an app-based digital therapeutic designed to provide behavioural therapy and cognitive behavioral therapy (CBT) to adult women diagnosed with OAB.
The PDTx is indicated for an eight-week treatment period and seeks to reduce OAB symptoms through evidence-based digital interventions.
Brendan Staunton is co-founder and CEO at Amara Therapeutics.
He said: “This is a huge milestone for Amara Therapeutics and takes us one step closer to revolutionising the treatment of OAB globally.
“Access to high-quality, affordable care is increasingly out of reach for millions of women who suffer from OAB.
“With fragmented networks, lack of specialists, and rising costs, the challenges in care delivery are frustrating for patients and clinicians alike.
Our mission is to ensure every patient has access to affordable, clinically proven behavioral therapy and the APPROVE trial will enable us to get this much needed innovation into the hands of patients who need it most.”
Recruitment for the trial is currently underway.
Women with ADHD are nearly twice as likely to experience perimenopause symptoms compared with women without ADHD, new research has revealed.
The study reported 54 per cent of women with attention deficit hyperactivity disorder had perimenopausal symptoms, compared with 30 per cent without the condition.
Among perimenopausal women with ADHD, 59 per cent reported psychological symptoms such as anxiety, low mood, irritability and fatigue.
Physical symptoms, including hot flushes, headaches or palpitations (a rapid or irregular heartbeat), occurred in 30 per cent with ADHD versus 14 per cent without.
Published in 2025, the research also found symptoms tended to start earlier for women with ADHD, peaking around ages 35 to 39, while those without ADHD reported their most severe symptoms around age 45.
The study suggests two explanations for the increased burden among women with ADHD.
Firstly, anxiety and lower socio-economic status are known risk factors for perimenopausal symptoms; both are more common among women with ADHD and chronic stress may amplify risk.
Secondly, oestrogen helps modulate ADHD symptoms.
Women with ADHD are at higher risk of premenstrual dysphoric disorder (PMDD) and other cycle-related issues because ADHD symptoms can intensify when oestrogen levels fall.
During perimenopause, oestrogen naturally declines, so women with ADHD may experience both typical perimenopausal symptoms and a worsening of ADHD symptoms at the same time.
The research also found a higher prevalence of lifetime post-traumatic stress disorder (PTSD) symptoms among women with ADHD.
When this factor was accounted for, women with ADHD who did not have PTSD still faced increased risks, though both risk and symptom intensity were reduced.
These findings suggest that interventions which reduce chronic stress and inflammatory responses could help women with ADHD navigate perimenopause more effectively.
Stanford graduates’ startup Clair is building a wearable hormone tracker for women, offering continuous, non-invasive monitoring.
The company, Clair, founded by Jenny Duan and Abhinav Agarwal, aims to build what its founders describe as a research-led, privacy-focused tool to help women see how hormone levels affect daily life.
Duan and Agarwal met in spring 2025 and began working on Clair shortly after. Over the past six months, they have been developing the technology and refining the company’s mission.
The device is designed to address gaps in women’s healthcare. Women remain underrepresented in medical research and clinical trials, leading to limited data and slower progress in understanding women’s health conditions.
According to Clair advisor and Stanford Medicine professor Brindha Bavan, hormone tracking in reproductive healthcare “improves our understanding of the function of and communication between the brain’s pituitary gland and ovaries or testes.
The pituitary gland is a small organ at the base of the brain that produces hormones regulating many bodily functions. The ovaries and testes are the primary reproductive organs that also produce sex hormones.
Hormonal health affects not only fertility and reproduction but also mental health, metabolism, energy levels and overall wellbeing.
Bavan said hormone tracking can “provide insight into menstrual cycle patterns and can aid with both diagnosing and assessing treatment for [various] conditions.”
“[Clair enables] patients [to] gain insight into their personal hormone fluctuations over different time periods,” Bavan said, “and share this information at healthcare visits to better understand and correlate any medical issues they are facing and avoid repeat blood draws.”
The device, which resembles a bracelet worn on the wrist, will connect to a mobile app, allowing all data processing to occur directly on the user’s phone rather than in external data centres.
“The device connects with an app so all of the processing happens on the app itself, not in a data centre like other devices. This is especially important given the current political climate around data privacy,” Agarwal said.
Clair also plans to pursue FDA approval and position itself as a medically credible device rather than solely a lifestyle product. The company is planning to launch a clinical trial at Stanford Medicine this spring.
Duan’s interest in women’s health and technology began as a Stanford undergraduate. At TreeHacks in 2024, she built apps focused on endometriosis, a condition where tissue similar to the lining of the womb grows outside of it.
She said a course on Philanthropy for Sustainable Development was particularly influential. “It was this class that sparked my interest in building a solution in [the women’s healthcare] space,” Duan said.
WUKA has announced a groundbreaking partnership with the Royal Yachting Association (RYA), including RYA Scotland and RYA Northern Ireland, supporting women and girls in sailing.
Building on WUKA’s growing #TackleAnything campaign – which has already reached thousands of girls across sports in the UK – this collaboration brings practical period solutions into sailing.
Together, WUKA and the RYA are committed to breaking down barriers so periods never limit confidence, participation, or performance on the water.
Ruby Raut, WUKA founder & CEO, said: “Partnering with the RYA has been incredibly important for us at WUKA.
“Sailing is an amazing way for women and girls to build confidence, and periods shouldn’t hold anyone back from enjoying the water or reaching their full potential.
“Through this partnership and our #TackleAnything campaign, we’re proud to provide practical solutions and innovative products that help female sailors feel comfortable, confident, and free to focus on learning, performing, and having fun.
“Breaking down barriers and supporting women to tackle anything — on land, at sea, and everywhere in between – has never felt more meaningful.”
WUKA, which stands for Wake-Up Kick Ass, shares the RYA’s commitment to inclusivity and empowerment.
In 2023, WUKA launched #TackleAnything, a campaign supporting women, girls and sportspeople with periods. Since its launch, the initiative has reached 3,576 girls across 46 clubs and partnered with a range of sports across the UK – from Scottish Gymnastics to Titans wheelchair basketball – helping young athletes play without limits and stay confident, comfortable, and in the game.
The brand offers period-friendly aquatic apparel and practical solutions that help women train and compete with freedom of movement and total assurance.
Through this partnership, WUKA will provide innovative period swimwear for young sailors across key RYA programmes, including the NI Sailing Team, the RYA Scotland Performance Pathway Programme, and the British Sailing Pathways Talent Academies.
By combining WUKA’s mission to challenge stigma with the RYA’s commitment to inclusion, the partnership ensures young sailors can focus on what matters most – learning, performing, and enjoying their time on the water – with confidence and comfort. RYA members will also receive a 10 per cent discount on WUKA products.
Sailing offers incredible benefits for women and girls, but time on the water can present unique challenges -particularly during menstruation.
Together, WUKA and the RYA are providing practical solutions that remove these barriers, helping young sailors participate fully and confidently in the sport.
Sara Sutcliffe, RYA CEO, said: “At the RYA, we have been making strides to break down barriers for women of all ages to help ensure they can experience the water in a supportive and positive environment.
“From education workshops and practical sessions, we want to make sure our female sailors are empowered and this partnership is another great example of how we can demonstrate possible tools to equip them to succeed”.
This partnership is part of the RYA’s wider commitment to making sailing a sport where women and girls can thrive. Alongside initiatives such as the Female Futures Group, the Women’s Race Officials Programme and all new Talent Academy Female Future’s Camps; it demonstrates a continued focus on removing barriers and creating meaningful opportunities across every stage of the sailing.
WUKA’s involvement ensures that practical solutions are available on the water, from innovative period swimwear to support resources, helping young sailors feel fully equipped and confident during training and competition.
By integrating these tools into RYA programmes, WUKA brings a new level of comfort and assurance to female athletes, allowing them to focus entirely on performance, enjoyment, and growth in the sport.
For any women and girls looking to learn more about sailing, visit www.rya.org.uk.
For more information on WUKA visit www.wuka.co.uk.
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