Novel vaginal bowel control system is effective, durable over 12 months for FI treatment
Richter HE, Dunivan G, Brown HW, 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.
Richter and colleagues characterized clinical success, effect on quality of life, and durability over 12 months of a novel vaginal bowel control device (Eclipse System; Pelvalon) for FI in a prospective cohort study. The device is a silicone-coated vaginal insert with a detachable pump and balloon that deflects the rectovaginal septum posteriorly, thus impeding the passage of stool in the rectum (FIGURE 2).
Study eligibility criteria and treatment protocol
Women were eligible for the study if they had 4 or more episodes of fecal soiling on a 2-week bowel diary and had FI for at least 6 months. Participants were excluded if they had prolapse outside the hymen, rectovaginal fistula, IBD, congenital anorectal malformation, urinary or colorectal infection, chronic pelvic or anorectal pain, pregnancy or planning pregnancy in the next 5 months, unmanaged chronic watery diarrhea, presence of an open wound or tear in the vagina, significant urogenital atrophy, or any psychiatric or neurologic disorder that would hinder the ability to participate.
Participants successfully fitted with the device (3 attempts were allowed) were entered into the study's run-in phase. Those who were successfully fitted and had a 50% or greater reduction in FI continued into the treatment phase with 12 months of follow-up.
Of the 137 women eligible for device fitting, 62% were successfully fitted. The 73 (86%) women who had a 50% or greater reduction in FI during the run-in period comprised the intent-to-treat study population. On average, these women were 61.3 years of age, with 70% white and 82% postmenopausal. At baseline, they had a mean of 14.1 episodes of FI over 2 weeks. (Prior to enrollment, 97.3% of women attempted self-management strategies, 17.8% to 23% failed conservative therapy, and 7.8% to 13.7% failed surgical therapy.) The follow-up rate at 12 months was 74%.
Study outcomes. The primary outcome was treatment success, defined as proportion of subjects with a 50% or greater reduction in FI episodes at 3 months; this outcome also was evaluated at 6 and 12 months. Secondary outcomes were the number of FI episodes and quality-of-life measures at 3, 6, and 12 months.
Treatment success, patient satisfaction high
In the treatment phase, women had sustained improvements in symptom severity and quality-of-life measures over 12 months. Treatment success was 73% at 3 months, 71% at 6 months, and 70% at 12 months. Complete continence was achieved in 46% of participants at 12 months, and major FI episodes (requiring immediate change of undergarments) decreased from 5.0 at baseline to 0.5 at 12 months. Quality-of-life measures were improved at 3 months, and improvement was sustained over 12 months. Satisfaction was 94% at 12 months.
Adverse events. No serious device-related adverse events occurred. Mild device-related adverse events were experienced by 45% of women during the fitting process and by 38% during treatment period. These included vaginal wall injury such as hyperemia and erosion; vaginal or pelvic discomfort; vaginal infection; constipation; and lower urinary tract issues such as urinary tract infection, urinary incontinence, and voiding dysfunction. No adverse events led to treatment discontinuation.
Strengths and limitations. Strengths of this study include that it was conducted at multiple clinical sites, had a large sample size, and had a 1-year follow-up period in a population with daily FI. A limitation was that only women who had a 50% or greater reduction in FI episodes during the run-in period were followed for 12 months; however, this was 86% of the original cohort. The use of a comparative group using other devices, such as anal plugs, would have strengthened this study.
The Eclipse intravaginal bowel control device (approved by the US Food and Drug Administration in 2015) provided a sustained 50% or greater reduction in FI episodes in more than 70% of women wearing the device for 1 year, with high patient satisfaction. Thus, for women who fail conservative treatment methods for FI, clinicians should consider referring them to a urogynecologist or specialist who is knowledgeable in fitting this vaginal bowel control device.
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