The NOTABLE Study - Neuromodulation for Accidental Bowel Leakage

STUDY BASICS

Are you a woman who suffers from accidental bowel leakage? If so, you may be able to participate in a research study to find out if an investigational new treatment called Percutaneous Tibial Nerve Stimulation (PTNS) is effective for women with this condition. Compensation is provided.

STUDY PURPOSE

Accidental bowel leakage, also called fecal incontinence, is the unintended leakage of solid or liquid stool from the rectum. While this common condition is usually not serious, it can significantly interfere with a woman’s daily life. Treatments for accidental bowel leakage exist but they do not work for everyone. The purpose of this study is to help researchers find out if a new treatment for accidental bowel leakage called Percutaneous Tibial Nerve Stimulation (PTNS) is effective for women with this condition. PTNS uses mild electrical pulses to stimulate the tibial nerve--a nerve at the ankle that is involved in sending messages to the bowel, rectum, and spinal cord. Researchers hope that stimulating this nerve will help control bowel function and reduce accidental bowel leakage. PTNS is an approved treatment for people who have accidental urine leakage, but is considered investigational in this study because it is not approved by the Food and Drug Administration (FDA) to treat accidental bowel leakage.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18 and up
• Have accidental bowel leakage
• Have tried other treatments which did not help your accidental bowel leakage, such as constipating medications and pelvic muscle strengthening exercises
• Not currently pregnant and do not plan to become pregnant while participating in the study
• Willing to download and use a bowel diary app on your smartphone (if you do not own a smartphone, the study team will provide one for use during the study)

WHAT PARTICIPANTS CAN EXPECT

Participation lasts a little over a year and has three parts: the initial part lasts 4 weeks, part 1 lasts 16 weeks, and part 2 lasts 9 months. You will be told at the end of each part whether you qualify for the next part. It is important to know that participants in this study will be randomly assigned (like the flip of a coin) to receive either Percutaneous Tibial Nerve Stimulation (PTNS) or a placebo treatment every week for 12 weeks. Participants are twice as likely to be assigned to PTNS than placebo. The placebo treatment looks and feels like PTNS but does not actually stimulate the tibial nerve. During the PTNS or placebo treatment, a very thin needle (like an acupuncture needle) is placed into the skin above the ankle. This needle is attached to a battery-powered stimulator that sends mild electrical pulses to the tibial nerve for about 30 minutes. The electrical pulses cause a tingling in the foot that is not uncomfortable. The needle is removed after 30 minutes. Participants will also complete a bowel diary on a smartphone app and answer questionnaires about general health and bowel symptoms. This study is funded by the NIH and is being conducted at the the University of Pittsburgh as well as 6 other sites of the Pelvic Floor Disorders Network.