FDA Grants Breakthrough Device Designation to leva System for Chronic Fecal Incontinence

The FDA has granted a breakthrough device designation to the leva Digital Therapeutic System for use as a first-line treatment in women with chronic fecal incontinence (FI) in women, according to Renovia, the developer of the device. The breakthrough device designation will expedite the development and regulatory review of this treatment system in female patients with FI. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device. Read more.

Source: Urology Times, November 1, 2021

Stewartville Plant Creates New Solution to an Old Problem

Automated machines quietly raise and lower trays of liquid silicone, water and a paraffin-like material in a Stewartville facility to create a new solution to an age-old medical condition that afflicts an estimated 2 percent of the world’s population. Multiple, carefully monitored dips create trays of 400 silicone inserts with a small bubble of liquid in four minutes. The inserts then move on to packaging to eventually be shipped to Minnesota Medical Technologies’ waiting customers in a growing number of countries. Designed by and created by a local team led by brothers Jim and Philip Conway, the patented myMiracle device is a small, lubricated anal insert to be used as a simple and discreet way to treat fecal incontinence. Read more.

Source: Post-Bulletin, Rochester, Minn., August 7, 2021

Astellas Makes Another Gene Therapy Play with Juventas Deal

Astellas has made another deal in the gene therapy category, licensing a candidate for treating faecal incontinence from US biotech Juventas Therapeutics. Terms of the deal haven’t been disclosed, but Astellas says it has taken an exclusive option on the non-viral gene therapy – called JVS-100 and in early-stage clinical development – in all world markets except China. It’s paying an upfront fee and will also fund preclinical and clinical studies of the therapy. JVS-100 is Ohio-based Juventas’ lead product candidate and delivers the gene sequence for stromal cell-derived factor-1 (SDF-1), a naturally occurring signalling protein that is thought to activate the body’s tissue repair pathways, using a plasmid vector. The agreement grants Astellas a licence to develop JVS-100 through phase 2a clinical studies, with an option to acquire the therapy for further development and commercialisation if all goes according to plan. Juventas has already tested the candidate in early-stage trials involving more than 180 patients in other indications, including repeat administrations, and says it has no significant side effects. Read more.

Source: PMLiVE, November 23, 2018

FODMAP Diet Helps Fecal Incontinence

Two-thirds of patients with fecal incontinence associated with loose stool experienced an improvement in symptoms when following a low FODMAP diet, a researcher reported here. “Fecal incontinence is an underappreciated complaint, and patients often suffer in silence,” said Stacy Menees, MD, of the University of Michigan in Ann Arbor, in a presidential plenary session at the annual meeting of the American College of Gastroenterology (ACG). In an earlier, large population-based study of more than 71,000 people, one in seven reported having had fecal incontinence at some point in their lives. Of these, one-third reported fecal incontinence in the last 7 days, which is often associated with diarrhea and loose stool. People with diarrhea have a 5.6-fold higher risk of fecal incontinence, and people with urgency have a more than 8-fold risk of diarrhea. “So if we are going to help people with fecal incontinence, the key is to concentrate on their stool consistency,” Menees said. Read more.

Source: MedPage Today, October 8, 2018

Nurses Welcome NICE Support for Irrigation Device for Constipation and Faecal Incontinence

A medical device for treating constipation and faecal incontinence has been recommended for health service use by the National Institute for Health and Care Excellence. Specialist stoma care nurses working with both children and adults affected by faecal continence problems welcomed the decision by NICE to back the use of the Peristeen transanal irrigation system.In new medical technology guidance published today, NICE said the “case for adopting” the Peristeen for managing bowel dysfunction was “supported by the evidence”. According to NICE, the system can “reduce the severity of constipation and incontinence, improve quality of life and promote dignity and independence”. Read more.

Source: Nursing Times, February 23, 2018

Learning to Live with Bladder and Bowel Incontinence

My Story – Submitted by: Shawn

Hello all! My name is Shawn and I am 39 years old and I am bowel and bladder incontinent. This started for me about 2 years ago. Well, l started out driving dump trucks for months and theses guys were dropping 2-3 thousand pound rocks into my truck. Jarred the snot out of me and knocked the wind right out of me several times. I started having issues with balance, feeling lightheaded all the time, blood pressure issues, couldn’t think or reason. And then one day I was sitting in bed talking to my wife, and wammo! I was wet. Soaked! Started having issues during the day peeing my pants and started wetting at night.Continue reading→

Gallbladder, Kidney Stones, and Incontinence

My Story – Submitted by: Anonymous

I’ve always had some bedwetting problems, but in the last few years they have become worse due to the fact that I have passed several kidney stones over the years, and it has affected my kidneys, and caused me to wet the bed more than usual. I have tried several different things, and none of them seem to have any affect on the bedwetting problem. Continue reading→

Functional Incontinence

Keeping a bathroom free of trip hazards will help a person with functional incontinence.

Functional incontinence is urinary or fecal leakage that occurs when the urinary or fecal body systems, respectively, are physiologically working fine. Functional incontinence is the result of mobility challenges with getting to the bathroom and/or dexterity challenges with removing clothing in a reasonable amount of time.Continue reading→

Bowel Incontinence or Accidental Bowel Leakage (ABL)

bowel incontinence occurs in the digestive system

Bowel incontinence or ABL occurs when stool or gas unexpectedly leaks from your rectum.

Bowel incontinence, which may also be referred to as fecal incontinence, anal incontinence or Accidental Bowel Leakage (ABL), is when stool or gas unexpectedly leaks from your rectum. Sometimes you feel the urge to have a bowel movement, but can’t reach a bathroom in time.

The U.S. National Institutes of Health’s Bowel Control Awareness Campaign reports that more than 18 million Americans have bowel incontinence. As with urinary incontinence, bowel incontinence affects people of all ages, races, and both sexes. However, it is more common in women than in men, and it affects the elderly more often than younger adults (although it is not a normal part of aging).Continue reading→

Neurogenic Bowel

A neurogenic bowel includes both the small and large intestine.

A neurogenic bowel is when your bowel malfunctions (it does not do what it is supposed to do) because of a disease or an injury to the nervous system. The bowel includes both the small and large intestine (also called the colon).Continue reading→