Independent evaluation of Analytica’s (ASX: ALT) PeriCoach treatment program for incontinence has revealed “significant” improvements in symptoms.
An independent US-based biostatistician analysed the PeriCoach real world data and noted a significant enhancement in pelvic floor strength over five weeks as well as a decrease in urine volume and leakage within three weeks.
The observational study involved using the PeriCoach version three, which was released in May last year.
PeriCoach includes a device, web portal and smartphone app to evaluated activity in pelvic floor muscles in real-time. The information is transmitted to a smartphone app and then uploaded to a cloud database where clinicians can monitor patients’ progress.
New PeriCoach users were asked to participate in a structured eight-week exercise regime and record urinary habits using the app-based diary.
According to Analytica, the PeriCoach eight-week challenge gave users reminders to exercise at least five times a week and enter bladder information into their diaries three days a week.
Participants were also asked to respond to a quality of life survey at the start of the challenge, half-way and at the end.
More than 60% of the participants who used PeriCoach for three weeks were described as experiencing “a highly significant reduction in leakage episodes” at this point and beyond.
By the end of the challenge, more than 75% of users reported an 80% reduction in bladder leakage and volume episodes.
“These results from PeriCoach version three users are without a doubt clinically significant on top of being statistically significant,” Analytica chairman Dr Michael Monsour said.
“As a clinician, I hear from women daily about their frustration in lack of change in continence symptoms after years of ‘Kegels at home,” he added.
“This echoes data that shows performing unassisted pelvic exercises, women report outcomes of 3% almost continent, 87% unchanged and 10% worse.”
Dr Monsour pointed out that PeriCoach offers women “clinical level guidance” within the privacy of their homes, and resulted in “noticeable improvement in continence symptoms in just a few weeks”.
Stress urinary incontinence affects one in three women around the world and is primarily a result of trauma to the pelvic floor muscles inflicted by childbirth, pregnancy and menopause.
Analytica chief executive officer Geoff Daly said the company planned to submit its data for publication in urological and women’s health journals.
“The biggest success here is that woman and clinicians can be confident in expectations for improvement in continence when pelvic floor rehabilitation is supported by PeriCoach,” Mr Daly added.