A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence

Abstract

Fecal incontinence is a common problem in community-dwelling women. Prevalence rates range from 12% to 25%. The average age at onset is between 47 and 55 years. This condition is debilitating and emotionally devastating. Most women with fecal incontinence are socially isolated and do not seek care. Although the cause of fecal incontinence is multifactorial, there is often a history of damage to the pelvic region caused by pregnancy and childbirth, Contributory causes include congenital, neurologic, functional, and traumatic alterations of the continence mechanism. Current nonsurgical treatment options for fecal incontinence include antidiarrheal agents, fiber supplements, biofeedback therapy, passive anal barriers, and injectable agents. All have shortcomings in efficacy, morbidity, cost, and/or patient compliance. Surgical options such as anal sphincteroplasty, dynamic graciloplasty, and the artificial anal sphincter have higher morbidity than noninvasive treatments, and long-term results are disappointing. A nonsurgical vaginal bowel-control system (Eclipse System) was recently approved by the Food and Drug administration and is now available. The Eclipse System provides a low-risk, effective, and easily reversible treatment for fecal incontinence. This device consists of a vaginal insert and pressure-regulated pump that reversibly occludes the distal rectum, allowing the patient to control her own bowel movements. The aim of this prospective, open-label trial was to assess the effectiveness and safety of the Eclipse system in women with fecal incontinence. Women with a history of fecal incontinence for at least 6 months and a minimum of 4 incontinence episodes over 2 weeks were fitted with the device. Patients served as their own controls. The primary efficacy outcome was defined as a 50% or greater reduction in fecal incontinence episodes at 1 month and was assessed using a bowel diary. Participants successfully completing 1 month of use were invited into an optional extended-wear period of another 2 months. Secondary outcomes were validated measures of symptom improvement: the Fecal Incontinence Quality of Life scale, the Modified Manchester Health Questionnaire, and the Patient Global Impression of Improvement. Device-related adverse events were recorded. The intention-to-treat population was defined as all participants successfully fitted with the device. The per-protocol population included intention-to-treat participants with a valid 1-month treatment diary. A total of 110 participants from 6 clinical sites entered the fitting assessment. Of these, 61 (55.5%) were successfully fit and underwent treatment. At 1 month, treatment success was demonstrated in 78.7% (48/61) of participants in the intention-to-treat population and 85.7 (48/56) of those in the per-protocol population (both comparisons, P < 0.001). More than 85% of patients considered bowel symptoms to be very much better (57.1%) or much better (28.6%). There was also significant improvement at 1 month in all Fecal Incontinence Quality of Life (P < 0.001) and Modified Manchester (P ≤ 0.007) subscales. Nearly 90% of participants were satisfied with the device, and 98.2% would recommend it to others. There were no serious device-related adverse events; the most common study-wide event reported by 22.7% of women was pelvic cramping or discomfort. The majority (64%) of adverse events occurred during the fitting period. This nonsurgical bowel-control device offers a completely new treatment option for women with fecal incontinence. Women successfully fitted and treated with the device show significant improvement in fecal incontinence symptoms assessed by objective and subjective measures. The device is effective in most patients and has no serious adverse effects. Patient acceptance and satisfaction are high. A longer-term outcome study is being designed to provide additional information on potential adverse effects and tolerability as well as efficacy.