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.