Non-Surgical Treatment for Women Suffering from Accidental Bowel Leakage

Accidental Bowel Leakage (ABL), also called Fecal or Bowel Incontinence, affects over 10 million women¹ in the U.S. It typically starts between ages 47 and 55³ but can start as early as the 20s². ABL becomes more common in women as they reach their 50s, 60s, and 70s². It can greatly impact quality of life, leading to social isolation and a higher need for long-term care⁴. The financial costs can also be high, with average yearly medical expenses around $2,400⁵. If surgery for a neuromodulation implant is needed, the cost can go up to about $36,000⁶.

Why do women experience Accidental Bowel Leakage (Fecal Incontinence)?
Fecal Incontinence can be caused by many factors, such as birth defects, nerve issues, muscle damage, or pelvic injuries³. For example, the muscles supporting the bladder, rectum, and uterus can weaken or get damaged due to pregnancy, childbirth, pelvic injury, aging, and other reasons. Further, having one pelvic floor disorder is linked to a higher risk of having others. In a study, 57% of women with Urinary Incontinence also had Fecal Incontinence or Accidental Bowel Leakage⁷

People with Accidental Bowel Leakage may experience:

• Urgency: A sudden, strong need to have a bowel movement
• Passive soiling: Passing stool without realizing it
• Incomplete emptying: Stool remaining in the rectum can leak out later
• Frequent bathroom trips: Feeling the need to go often
• Staining: Stool stains in underwear

Living with Accidental Bowel Leakage may involve:

• Fear of accidents and unpleasant odors
• Social embarrassment, shame, and avoiding social activities
• Limited mobility and planning life around bathroom access
• Financial strain, possibly being unable to work or work as usual
• Challenges with intimacy
• Reduced physical activity, leading to weight gain or other health issues
• Disrupted sleep due to bathroom needs
• Fewer wardrobe choices
• Difficulty traveling, needing to pack extra clothes, sheets, and bags
• Feelings of isolation and depression
• Skin irritation

Eclipse System for Bowel Control

The Eclipse System is a newer, FDA cleared, and non-surgical option for treating Accidental Bowel Leakage in women. It works as well as surgically implanted nerve stimulation devices³ like Axonics or InterStim. Eclipse is available by prescription and can be conveniently fit in a doctor’s office. It’s designed for adult women with Accidental Bowel Leakage and can be used alone or with other treatments to improve bowel control.

Click to learn more about Eclipse: The Eclipse System How it Works (youtube.com)

How does Eclipse work?

Eclipse is a removable vaginal insert with a small balloon that gently presses on the rectum to stop stool from passing. Placed in the same location as a tampon, the patient inflates the insert’s balloon to prevent stool from passing using a separate small pump. When it’s time for a bowel movement, the patient deflates the balloon with the same pump, allowing stool to pass normally. Afterward, the balloon is reinflated to block stool again. The separate pump is compact and can be easily stored in a handbag.

Learn more about how the Eclipse Insert works:

How the Eclipse System Works – An Interview with Dr Holly Richter (youtube.com)

UNINFLATED DEVICE for bowel movement        INFLATED DEVICE to prevent stool leakage

Accidental Bowel Leakage may be treated by different types of doctors depending on the cause. Here are the specialists who may help:

• Urogynecologists (Urogyns): These doctors specialize in treating Pelvic Floor Disorders in women, including Urinary and Fecal Incontinence. They are experts in fitting devices like pessaries, which is similar to fitting the Eclipse Insert. Urogyns are the most likely physician to treat Accidental Bowel Leakage with the Eclipse System.
• OB/GYNs: These doctors focus on pregnancy and female reproductive health. Some may treat Accidental Bowel Leakage, such as postpartum cases, or refer patients to a Urogyn or other specialist depending on the cause.
• Colorectal Surgeons: These surgeons treat diseases of the intestines, colon, rectum, and anus. While they handle complex cases requiring surgery, they may refer patients without a surgical need to other specialists.
• Gastroenterologists (GIs): These doctors focus on digestive system health and perform procedures like colonoscopies to diagnose issues. They treat conditions such as pancreatic disease, irritable bowel syndrome (IBS), GI cancers, and acid reflux.

Will Eclipse work for me?

If you are a woman with Fecal Incontinence and have no vaginal infections or open wounds, you may be a candidate for Eclipse. In the LIBERATE study, 62% of women were successfully fit⁴.  Since Eclipse is a non-invasive option, it can be tried before considering more invasive treatments like surgery. Eclipse is easily removable, making the therapy low risk and reversible.

Patient Experiences with Eclipse:

Women share their personal experiences with Eclipse (youtube.com)

 How do I get fit with Eclipse?

Getting fit for Eclipse is done conveniently from your doctor’s office. First, your healthcare provider will check your vaginal health to make sure you’re ready for Eclipse. In some cases, they might prescribe an estrogen cream beforehand to improve tissue health.

Once you’re ready, your doctor will use sizing rings (similar to those used for a pessary) to find the right size insert for you. Then, a temporary, disposable Eclipse Trial Insert will be used to confirm the overall insert fit. Different sizes can be tried to ensure it’s comfortable and effective for your body.

Your doctor may let you use the Trial Insert at home for up to two weeks to see how it fits, how comfortable it is, and how well it works for you. If the trial is successful, you’ll receive your long-term Eclipse Insert, which lasts for 12 months. After a year, you’ll return to the doctor for a replacement.

Eclipse Effectiveness

The Eclipse system has been tested in over 200 women¹⁰.

In the LIFE study³, 86% of women reported treatment success* after 1 month of use. The average number of Fecal Incontinence episodes dropped from 5.8 per week before Eclipse to 1.1 per week after Eclipse at 1 month with 41% of participants having no accidents. Eclipse not only reduced accidents but also improved bowel control symptoms.  These symptom improvements included less urgency, less incomplete bowel movements, less frequent bowel movements, and less liquid stool³.

In the longer-term LIBERATE study⁴, 84% of women reported success* at 3 months, and 94% of those who continued in the study reported success at 12 months. The number of Fecal Incontinence episodes went from 7.1 per week before Eclipse to 1.5 per week at 3 months, 1.1 per week at 6 months, and 0.9 per week at 12 months after Eclipse⁴. At the end of the 12-month study, 46% of women reported no Fecal Incontinence episodes⁴.

The fit rate for Eclipse during the LIBERATE study was 62%⁴, meaning it won’t work for everyone. However, because Eclipse is non-surgical and can be tried in a doctor’s office before committing, it’s easy to see if it works for you. In the LIFE study, 96% of women found Eclipse “comfortable or could not be felt”, and 98% said they would recommend it to a friend³.

Eclipse Safety

Eclipse has been proven to be safe and low risk in several clinical studies, including the LIFE³ and LIBERATE⁴ studies. No serious device-related adverse events were reported. However, some women did experience mild adverse events**. In the LIFE study, the most common issue was “pelvic cramping or discomfort”, mostly during the fitting period³. The next most common issues were urinary incontinence “or urinary urgency or frequency”. In the LIBERATE study⁴, the “most common adverse event was vaginal wall injury, with most adverse events occurring during fitting period.”  None of these events caused women to leave the LIBERATE study.

Summary

Eclipse is a low-risk, non-surgical, and highly effective solution for Accidental Bowel Leakage. With just a simple visit to your doctor’s office, you could regain bowel control. Unlike surgically implanted devices, Eclipse is easily placed and removed, so you can use it as needed. It can also be combined with other bowel control treatments to give you more confidence in your daily life.

Talk to your doctor today to see if Eclipse is right for you.

 Do you need help finding a physician to treat your Accidental Bowel Leakage?  Try our Find A Provider tool or contact us directly via Laborie Contact Form.

For more information from physicians and patients, explore our interactive Eclipse experience below

References:

1. Nygaard et al. Prevalence of Symptomatic Pelvic Floor Disorders in U.S. Women. JAMA 2008; 300(11):1311-1316.
2. Bharucha AE et al. Prevalence and Burden of Fecal Incontinence: A Population-Based Study in Women. Gastroenterology 2005;129:42–49
3. Richter HE, Matthews CA, Muir T, et al. A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence. Obstetrics & Gynecology 2015; 125(3):540-547
4. Richter HE, Dunivan G, Brown H, et al. A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2019; 25:113-119
5. Xu X et al. Economic Cost of Fecal Incontinence. Dis Colon Rectum 2012; 55: 586–598
6. Bernstein et al. Three-Year Cost-effectiveness […] Management of Fecal Incontinence. Clinical Therapeutics. 2014; 36(6):890–905
7. Lawrence et al. Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women. Am College of Obstet Gynecol 2008; 111(3):678-685
8. Brown et al. Factors associated with care seeking women with accidental bowel leakage. Female Pelvic Med Reconstruct Surg. 2013; 19: 66-71
9. ACOG Practice Bulletin #210, April 2019
10. Eclipse Instructions for Use – ART-0459 Rev.01

Study definitions:

*Study success criteria defined as at least a 50% reduction in fecal incontinence episodes in the post-Eclipse period versus the pre-Eclipse period.^3,4

**Adverse event definitions:

• The LIFE Study defined adverse events “as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in consented participants, whether or not related to the investigational medical device, were documented.”³
• The LIBERATE Study defined adverse events “as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), were documented, and relationship to the investigational device was assessed.”⁴

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