FDA expands use of PeriCoach at-home pelvic floor trainer device and smartphone app for sexual health
Analytica announced that the US Food and Drug Administration (FDA) clarified use for PeriCoach to potentially improve sexual sensation or satisfaction and orgasm potential in women.
“This clarification for PeriCoach provides a critical level of certainty when women and clinicians consider PeriCoach to improve sexual function and satisfaction,” said Megan Henken, Vice President Marketing for Analytica. “While it is empowering for women to self-manage pelvic floor related issues from bladder leakage to sexual function, the product they use has to be reliable.”
Last month, FDA approved PeriCoach as an over-the-counter (OTC) treatment for treatment of mild, moderate and stress urinary incontinence (UI) and urge incontinence.
Studies have found that that sexual complaints, from low libido to problems with sexual arousal to inability to achieve orgasm, are common among women with pelvic floor disorders.
“Unfortunately, many women feel that decreased sexual function is an inevitable part of aging,” said Leslie Rickey, MPH, MD, Associate Professor of Urology and of Obstetrics, Gynecology and Reproductive Sciences; Fellowship Director, Female Pelvic Medicine and Reconstructive Surgery, Yale School of Medicine. “But women should know there are self-help strategies, and now home pelvic floor training support with PeriCoach can help improve pelvic floor muscle strength and sexual function at ANY age. Sexual function can also be affected by psychological, biological or interpersonal factors and may require a multi-modal treatment approach in addition to pelvic floor muscle rehabilitation. It is important to note that women who experience pain with sexual activity should first be evaluated by their gynecologist or PCP.”
Since its introduction in 2015 as a prescription product, PeriCoach, designed by a woman engineer, has been studied and clinically evaluated by clinicians including women’s health physical therapists, urogynecologists, OBGYNs and urogynecological nurses. Data and case reports have been presented and published in peer-reviewed forums.
Analytica intends to pursue further pelvic floor indications where pelvic floor exercise is an effective conservative treatment option, such as; mild pelvic organ prolapse and fecal incontinence.
For more information please visit the PeriCoach website for pelvic floor muscle training support, updates, tips and special savings. PeriCoach has regulatory clearance in Australia, and has CE mark and USFDA 510(k) clearance. The product is available for sale in Australia and New Zealand, UK and Ireland, and in the USA.
What: PeriCoach is the first training device, web portal and smartphone app to take the guesswork out of pelvic floor muscle training.
How: Three biosensors are built into the PeriCoach device to detect the strength of each muscle contraction. The app collects and analyzes the readings and gives a picture of how the user is doing over time. PeriCoach is also the first system that can send reports from the smartphone to a clinician or pelvic health specialist.
Why: Urinary incontinence (UI) is characterised by an involuntary leak that often occurs while running, coughing, laughing or sneezing or even during sexual activity, or not being able to “hold it” when feeling a sudden urge.
Pelvic floor muscle training is recommended as first-line treatment for UI by the American College of Physicians based on an analysis of literature from 1990 through 2013 recently published in Annals of Internal Medicine.1 Yet, many women who could benefit from training do not stay with it because they are unsure if they are squeezing the right muscles or making progress. As a result, they give up and resort to using panty-liners or cumbersome pads to manage, rather than address, the problem.
Who: The PeriCoach device is for women who regularly follow doctor-recommended treatment for urinary incontinence (UI). It is an embarrassing and often debilitating problem millions of women experience particularly after childbirth or menopause, affecting 1 in 3 women worldwide.
Where: The device is meant for home use and is available directly to women as well as clinicians and physios. The PeriCoach was designed with help from professionals in the pelvic health field, to ensure the programs are beneficial in the privacy of your home or with assistance from a clinician.
When: The PeriCoach device was available for purchase as of the 24th November 2014.
- Handa, VL, Cundiff G, Chang H, Helzlsouer KJ, Female sexual function and pelvic floor disorders, Obstet Gynecol, 2008 May 111 (5): 1045-1052 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2746737/