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NOTABLE: Neuromodulation for Accidental Bowel Leakage

Many women suffer from accidental bowel leakage or leakage of stool from the rectum. Investigators at Magee-Womens Hospital, working with the National Institutes of Health’s Pelvic Floor Disorders Network, are interested in learning more about women with this condition and new treatments for this condition.

One new treatment for accidental bowel leakage is neuromodulation. Neuromodulation involves stimulating nerves to change how the body functions. Percutaneous Tibial Nerve Stimulation (PTNS) is one form of neuromodulation. PTNS uses mild electrical pulses to stimulate a nerve at the ankle (the tibial nerve). This nerve sends messages to your spinal cord, bowel, and rectum that may help control bowel function, including accidental bowel leakage. During PTNS, a very thin needle is placed into the skin above your ankle. This needle is attached to a battery-powered stimulator which sends mild electrical pulses to the tibial nerve for about 30 minutes. The electrical pulses cause a tingling in your foot which is not uncomfortable. The needle is removed after 30 minutes. This stimulation treatment is repeated every week for 12 weeks.

PTNS is an approved treatment for men and women who have accidental urine leakage. Small studies have shown that PTNS also reduces accidental bowel leakage. PTNS for accidental bowel leakage is experimental since it has not been approved by the Federal Drug Administration (FDA).

The NOTABLE study will compare PTNS to a ‘sham’ stimulation in women with accidental bowel leakage to learn if PTNS is better than sham at preventing accidental bowel leakage. The sham stimulation will provide a similar sensation of tingling in the foot, but it will not stimulate the tibial nerve. A sham treatment is also known as placebo.

This study will use an electronic bowel diary that is an app downloaded onto a smartphone. The phone diary was selected because it is more accurate and generally more convenient than a paper diary. Additionally, the phone app bowel diary will enable the study team to send reminder notifications to your phone twice daily to help you remember to report all your bowel events (bowel movements and leakage episodes). The notification will appear as a pop-up bar at the top of the phone screen which will disappear shortly after appearing.

Women who participate in this study will attend a maximum of 16 visits over the course on one year. They will complete bowel diaries on their smart phones and questionnaires on a tablet compute while in the office.

If you are interested in learning more about this important study please contact Jacqueline Noel at 412-641-6679, or Judy Gruss at 412-641-5388.

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