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PeriCoach® Clinical Study and Real-World Data Insi ...
PeriCoach® Clinical Study and Real-World Data Insights - Chelsea Cornelius, BME(Hons)/BA & MBiomedEng
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Pdf Summary
The PeriCoach is an eHealth system designed to provide pelvic floor muscle therapy (PFMT) through consistent biofeedback and data collection. Two studies were conducted to assess its effectiveness: a randomized controlled trial (RCT) and a real-world data (RWD) study. In both studies, women used the PeriCoach system, which includes a vaginal probe, smartphone app, web portal, and support from clinicians. The PeriCoach app allows users to record symptoms and strength measurements, which are obtained through force sensors in the probe. The RCT showed significant improvement in quality of life and sexual function scores, as well as an increase in pelvic floor muscle strength with the use of PeriCoach compared to traditional PFMT. The RWD study also demonstrated improvement in strength and a reduction in urine leakage volume and episodes. An updated version of PeriCoach (V3) was introduced, which included real-time technique guidance and an 8-week program, resulting in even more significant improvements. Comparisons between the RCT and RWD studies suggested that if V3 had been used in the RCT, the improvements would have been statistically significant. In conclusion, the PeriCoach system was found to support compliance, improve strength, and have positive outcomes for PFMT. The inclusion of real-time technique feedback and a structured program in the updated version would likely lead to even greater improvements. eHealth systems like PeriCoach allow for automated data collection without intervention bias and are accessible to patients. The study was internally funded and the author is an employee of Analytica Ltd.
Keywords
PeriCoach
eHealth system
pelvic floor muscle therapy
biofeedback
data collection
randomized controlled trial
real-world data study
vaginal probe
smartphone app
web portal
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