Nerve stimulation study offers hope for women with fecal incontinence
August 8, 2019
Millions of women around the world struggle with fecal incontinence – a debilitating and embarrassing condition that causes uncontrolled leakage of stool and gas. Also known as accidental bowel leakage (ABL), the condition severely and negatively impacts quality of life for 40% of women who have it.
Current therapies are largely ineffective:
- ABL surgeries can be expensive and typically have poor long-term outcomes
- Nonsurgical options can make stools firmer but don’t often fully improve the incontinence
- New therapies such as radiofrequency or bulking injections to narrow the rectum can improve symptoms up to approximately 50% in the short term, but little long-term data are available
Unfortunately, many patients feel ashamed or uncomfortable discussing bowel issues with their doctor. As such, only about 30% of women with ABL seek medical care. The rest suffer in silence.
It’s time to end the stigma around ABL and give women their lives back. UT Southwestern has joined a clinical study to find out whether a low-risk and relatively low-cost nerve procedure approved for some bladder issues can also control ABL symptoms.
What is PTNS for fecal incontinence?
In traditional Chinese acupuncture, the tibial nerve, which runs from the lower spine to the ankle, is an acupuncture point to reduce pelvic issues such as bladder dysfunction, pelvic pain, and impotence.
Percutaneous tibial nerve stimulation (PTNS) applies electrical currents to the tibial nerve, retraining the nerve branches to work properly – an event known as neuromodulation. PTNS has proven effective for overactive bladder and urgency urinary incontinence, and small studies suggest it might improve ABL symptoms.
However, PTNS is not yet approved by the U.S. Food and Drug Administration to treat ABL. We need more data, which we hope to gather in the Neuromodulation for Accidental Bowel Leakage (NOTABLe) trial.
UT Southwestern is one of seven academic medical centers across the U.S. to participate in NOTABLe, which is funded by the Eunice Kennedy Shriver National Institute for Child Health and Human Development, a branch of the National Institutes of Health.
Today, the only way to try PTNS for accidental bowel leakage is to enroll in NOTABLe at a participating medical center:
- Brown University/Women & Infants Hospital of Rhode Island
- Duke University
- University of California San Diego
- University of Alabama at Birmingham
- University of Pennsylvania
- University of Pittsburgh
- UT Southwestern
Doctors at these centers are enrolling 359 women to the trial to determine whether PTNS can benefit women with ABL.
What does the NOTABLe clinical trial involve?
Two-thirds of participants will be randomly selected to receive 12 weekly, 30-minute sessions of PTNS. The remaining third will receive a placebo procedure for the same timeframe. Women who show improvement on PTNS can continue with monthly therapy to complete one year of treatment.
To be eligible, patients must have experienced ABL episodes approximately twice a week for three months or longer. Patients must also have tried the following approaches to manage symptoms:
- Strengthening their pelvic floor muscles (such as doing Kegels)
- Making dietary changes, such as eating a high-fiber diet
- Taking constipating medication
There is no cost to participate in the study. Participants will be compensated based on the duration of their therapy. Women who participate for the full year will be compensated approximately $1,275.
Interested in joining the study? Call UT Southwestern for an initial eligibility screening by phone:
- For English, call Agnes Burris, RN, at 214-645-3833
- For Spanish, call Juanita Bonilla at 214-648-2507
What women should know about ABL
ABL can affect anyone of any age. However, it is most common in women age 65 and older. An estimated 2% to 20% of women living in senior communities and 46% of women in nursing homes have ABL.
While there are many possible contributing causes, ABL is strongly associated with conditions that damage or interfere with the anal sphincter – the group of muscles that control the release of stool. Some of these include:
- Conditions that cause loose stools, such as irritable bowel syndrome or inflammatory bowel diseases
- Constipation with "overflow" incontinence of loose stool around the hard, constipated stool
- Nerve and muscle conditions such as diabetes, stroke, or multiple sclerosis
- Complicated vaginal childbirth that damages the anal sphincter