Pelvalon has created a new product and new approach for better controlling accidental bowel leakage (ABL). It is intended to treat ABL in women 18 to 75 years old who have had four or more fecal episodes in a two-week period. The product is an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of ABL episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the person wearing it can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning.
The device consists of a silicone base and a posteriorly directed balloon. The patient controls the inflation pump, inflating the balloon to add pressure and interrupt stool passage, and deflating it to allow bowel movements.
Treating bowel control problems through the vagina is a new concept. There is another product in clinical trials to control stress urinary incontinence (SUI) that is a balloon which is vaginally inserted. Its called the Solace Bladder Control Procedure. Learn more about the trial being conducted in 15 cites.
The Eclipse System Insert, which is not yet approved by the FDA and is still investigational, is placed in the same location as a tampon. The user inflates a balloon on the Insert, which puts pressure on the rectum and is designed to protect against unwanted stool passage. Women can remove the insert at any time. The Eclipse System is a non-invasive treatment option that does not require surgery.
Does It Actually Work? It has been clinically tested with 61 women. Following are the findings:
|Here the balloon is inserted, inflated and putting pressure on the bowel|
- The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of episodes while using the device, as compared to baseline from 5.9 per week to 1.1.
- 85% of study participants considered their bowel symptoms 'very much better' or 'much better' after one month.
- There was significant improvement across all fecal quality of life measures.
- About 40% of women became totally continent.
- Study participants had a mean age of 61 years. Thirty percent were obese. Nearly 50% had prior hysterectomy, 8% had prior pelvic prolapse surgery, and 15% had prior urinary incontinence surgery.
Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).
How Its Used. The product will begin placement in localized urogynecologists offices and will expand over time to ob/gyns. A woman will visit her doctor who will fit her for the most appropriate size (three base sizes and two balloon sizes). The patient will check for comfort by standing, sitting, etc. before leaving the office. A return visit is expected in a week and following that the product can be used until the next exam (yearly). A woman can remove it to clean it or for any other purpose at any time.
The device isn’t a good option for everyone, however. After being fitted with the device, approximately 40 women who were screened and fitted did not continue. This rate of discomfort or nonacceptance is similar to that associated with pessaries. Also see Poise Impressa.
The initial fitting procedure for the new bowel control device requires a little more provider and patient training, beyond what is needed for use of a traditional vaginal pessary. Patients in the study could put the device in and take it out as they wished. Most patients used it all day long, and some took it out at night. Patients were instructed to take it out once or twice a week to wash it. The cost is expected to be in the range of $1200 to $1400 when it becomes available later this year.
Further Reading & Resources
ABL conversation starter
ABL - See who has it
The Mayo Clinic Fecal Incontinence
Muscle Damage Was Leading to My ABL
The Cleveland Clinic - Colorectal Center for Functional Bowel Disorders
The Underlying Causes of ABL
National Association for Continence
When Neurological Disorders Cause ABL
Your Guide to Constipation Related ABL
The International Foundation of Functional Gastrointestinal Disorders
How Pelvic Floor Dysfunction Leads to ABL, and What You Can Do About It
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