Analytica Medical has announced the commencement of patient recruitment for the first prospective multi-centre trial of The PeriCoach System, a personalised device, web portal and smartphone app that provides real-time biofeedback for pelvic floor muscle exercises.
While the trials are not required for registration, they provide Analytica with the opportunity to differentiate The PeriCoach System and could produce efficacy information for reimbursement studies.
Weak pelvic floor muscles can contribute to bladder leakage and sexual disfunction. Pelvic floor muscle exercises (PFME) are recommended by the American College of Physicians as first-line non-pharmacological treatment for urinary incontinence.
The PeriCoach system provides real-time biofeedback to enhance the performance and effectiveness of performing PFME.
The PeriCoach system’s patented technology is a result of five years research and testing to international standards.
The PeriCoach system has achieved registration as a medical device with the TGA (Australia), CE-marking for Europe, and FDA clearance in the US.
The PeriCoach trial is investigating urinary incontinence and has a secondary endpoint investigating quality of life improvements, including sexual function.
100 patients will be recruited at 4 Australian sites over the coming months, with each patient monitored over 20 weeks.
Dr Ailsa Wilson Edwards, urological surgeon at Continence Matters in Adelaide, will serve as lead investigator.
The PeriCoach recently received 510(k) clearance by the FDA allowing marketing into the US where it is a prescription-only device.
The product will shortly be launched and available for sale in the US. It is also cleared for sale and available to the public in Australia without prescription.
Clinician engagement is a key part of the global marketing strategy.
Analytica recently demonstrated the PeriCoach system at the Royal College of Obstetricians and Gynaecologists (RCOG) World Congress at the Brisbane Convention Centre.
The company will be presenting two scientific posters at the Simon Foundation “Innovating for Continence” meeting in Chicago later this week.
“We are excited to take this important next step in our continuing efforts to help the clinical community and women reduce or eliminate urinary incontinence and other pelvic floor disorders such as sexual dysfunction.” said Geoff Daly, Analytica CEO.
“Effective pelvic floor muscle exercises are a critical component of any comprehensive treatment program for urinary incontinence. Our goal with this trial is to partner with clinical centres and the professional community to understand how PeriCoach help improve the compliance and effectiveness of these proven exercises.”