Irish women’s health company Amara Therapeutics has completed recruitment of 596 women into a US randomized controlled trial of its digital treatment for overactive bladder.
The APPROVE trial is testing RiSolve, Amara’s prescription app-based treatment, against standard behavioral education in women with overactive bladder (OAB). RiSolve delivers an eight-week treatment programme through a smartphone app, with clinicians able to follow patients’ progress through an online portal. The study is sponsored by MedStar Health Research Institute and has recruited participants across multiple US sites.
The scale makes it a substantial clinical test for a women’s health digital therapeutic. Rather than looking simply at whether women use or engage with the technology, researchers will assess whether RiSolve meaningfully improves symptoms and quality of life.
“The scale and rigor of APPROVE are particularly important to us,” said Brendan Staunton, CEO and co-founder of Amara Therapeutics.
“We want RiSolve to be supported by high-quality clinical evidence and to demonstrate not simply whether women use a digital treatment, but whether it meaningfully improves their symptoms and quality of life.”
Principal investigator Alexis Dieter, MD, said rigorous research was important in assessing approaches that could make behavioral treatment more accessible to women with OAB.
“Overactive bladder can have a profound impact on quality of life,” she said.
Designed for adherance
OAB causes urinary urgency and frequency, waking during the night to urinate and, for some women, urgency urinary incontinence. Behavioral therapies such as bladder training and pelvic floor exercises are recommended early in treatment, but accessing and sticking to them can be difficult.
Through the app, RiSolve combines bladder training, urge suppression and pelvic floor training with cognitive behavioral therapy, bladder health education and other interventions. Patients can log symptoms and bladder data as they work through the programme, while healthcare providers can follow their progress through a web-based dashboard.
Women in the APPROVE trial were randomized to either RiSolve or standard behavioral education. Its main measure is whether symptoms improve after eight weeks, with researchers also looking at quality of life, urinary frequency, nocturia, incontinence, treatment satisfaction, adherence and safety.
Participants will then be followed at six and 12 months to see whether any improvements last and whether they go on to use other OAB treatments.
With recruitment now complete, Amara said the focus will move to completing the eight-week primary endpoint follow-up and analysing the results.
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