Location

Suwanee, GA

Start Date

10-5-2021 12:00 AM

End Date

13-5-2021 12:00 AM

Description

The silent epidemic of urinary incontinence (UI) is described by the World Health Organization (WHO) as one of the last medical taboos and it interferes with the lives of millions of women. Only 25% of those with UI seek care, and of those, less than half receive treatment. The most common type of UI is stress urinary incontinence (SUI) which affects approximately 40% of community-dwelling women. The International Continence Society defines SUI as the complaint of involuntary leakage of urine on effort or exertion or with sneezing or coughing. This occurs in response to sudden increases in intra-abdominal pressure (IAP) during exertional activities in the presence of weak pelvic floor muscles (PFM) which fail to provide enough resistance to dissipate IAP. Pelvic floor muscle (PFM) training is considered a first-line treatment for SUI. Since these muscles are out of sight and do not move a joint it is difficult for women to contract them appropriately, consequently many recruit other muscles or perform a bearing down maneuver which can exacerbate their SUI or potentially lead to pelvic organ prolapse. This preliminary study describes the effects of INNOVO® shorts, a recent FDA cleared wearable neuromuscular electrical stimulation garment on pelvic floor function in women with and without SUI.

Methods: Thirty females (10 SUI) provided informed consent. Each donned the INNOVO® shorts in standing with intensity modified to elicit PFM contractions visible on ultrasound imaging (US). Transabdominal (TAUS) and transperineal (TPUS) US cineloops were acquired using a curvilinear transducer. Appropriate contractions were defined as cranial (TAUS) and cranioventral (TPUS) displacement of the bladder base and neck respectively.

Results: Pelvic floor contractions were observed for all participants. The mean displacement of the bladder base via TAUS was 0.96 cm (SD 0.53cm). TPUS confirmed INNOVO® elicited pelvic floor contractions and changed the anorectal angle with concomitant anterior urethral displacement towards the pubic symphysis.

Conclusions: Pelvic floor training is a first-line intervention for many pelvic floor disorders. The ability to perform contractions is essential to successful outcomes but is challenging for many. These individuals may use vaginal/anal probes with electrical stimulation (ES) to facilitate contractions. However, the evidence regarding this method reports contractions occurring in only 11-16% in addition to limited compliance due to large current densities, pain, and or vaginal/anal bleeding. INNOVO® has extremely low current density and elicits comfortable contractions. Efficacy is high in SUI with 93% improved in 4 weeks and 87.2% dry or categorized as mild. Given the quality of the elicited contractions noted on US and reported outcomes, INNOVO® offers a safe and effective non-invasive home treatment option for those with SUI and potentially other pelvic floor disorders such as fecal incontinence and pelvic organ prolapse.

Embargo Period

6-3-2022

Available for download on Friday, June 03, 2022

COinS
 
May 10th, 12:00 AM May 13th, 12:00 AM

A Short Story - The Effect of INNOVO® shorts on Pelvic Floor Function

Suwanee, GA

The silent epidemic of urinary incontinence (UI) is described by the World Health Organization (WHO) as one of the last medical taboos and it interferes with the lives of millions of women. Only 25% of those with UI seek care, and of those, less than half receive treatment. The most common type of UI is stress urinary incontinence (SUI) which affects approximately 40% of community-dwelling women. The International Continence Society defines SUI as the complaint of involuntary leakage of urine on effort or exertion or with sneezing or coughing. This occurs in response to sudden increases in intra-abdominal pressure (IAP) during exertional activities in the presence of weak pelvic floor muscles (PFM) which fail to provide enough resistance to dissipate IAP. Pelvic floor muscle (PFM) training is considered a first-line treatment for SUI. Since these muscles are out of sight and do not move a joint it is difficult for women to contract them appropriately, consequently many recruit other muscles or perform a bearing down maneuver which can exacerbate their SUI or potentially lead to pelvic organ prolapse. This preliminary study describes the effects of INNOVO® shorts, a recent FDA cleared wearable neuromuscular electrical stimulation garment on pelvic floor function in women with and without SUI.

Methods: Thirty females (10 SUI) provided informed consent. Each donned the INNOVO® shorts in standing with intensity modified to elicit PFM contractions visible on ultrasound imaging (US). Transabdominal (TAUS) and transperineal (TPUS) US cineloops were acquired using a curvilinear transducer. Appropriate contractions were defined as cranial (TAUS) and cranioventral (TPUS) displacement of the bladder base and neck respectively.

Results: Pelvic floor contractions were observed for all participants. The mean displacement of the bladder base via TAUS was 0.96 cm (SD 0.53cm). TPUS confirmed INNOVO® elicited pelvic floor contractions and changed the anorectal angle with concomitant anterior urethral displacement towards the pubic symphysis.

Conclusions: Pelvic floor training is a first-line intervention for many pelvic floor disorders. The ability to perform contractions is essential to successful outcomes but is challenging for many. These individuals may use vaginal/anal probes with electrical stimulation (ES) to facilitate contractions. However, the evidence regarding this method reports contractions occurring in only 11-16% in addition to limited compliance due to large current densities, pain, and or vaginal/anal bleeding. INNOVO® has extremely low current density and elicits comfortable contractions. Efficacy is high in SUI with 93% improved in 4 weeks and 87.2% dry or categorized as mild. Given the quality of the elicited contractions noted on US and reported outcomes, INNOVO® offers a safe and effective non-invasive home treatment option for those with SUI and potentially other pelvic floor disorders such as fecal incontinence and pelvic organ prolapse.