BACKGROUND: Fecal incontinence is a common, distressing condition with limited surgical options. OBJECTIVE: This study examines the results of magnetic sphincter augmentation in patients with severe fecal incontinence. DESIGN: This was a single-center, prospective, nonrandomized investigation. SETTING: This study was conducted in a private colorectal practice. PATIENTS: The cohort included all of the patients implanted with magnetic sphincter augmentation between January 2012 and October 2013. INTERVENTION: Magnetic sphincter augmentation was studied. MAIN OUTCOME MEASURES: Adverse events, symptom severity, quality of life, bowel diary, and manometry data were collected. RESULTS: Eighteen patients (15 women), with mean age of 69 years (range, 31-91 years), were implanted with magnetic sphincter augmentation. Follow-up ranged from 353 to 738 days. Previous treatment consisted of peripheral nerve evaluation test in 10 patients (56%), 2 patients (11%) with previous permanent sacral nerve stimulation, and 1 patient (6%) with previous implantation of an artificial bowel sphincter. Implantation was successful in 17 (94%) of 18 patients. Five patients (29%) had postoperative pain, and 5 patients (29%) had temporary swelling and erythema in both gluteal regions after the implantation. No devices were explanted during the follow-up. Cleveland Clinic Incontinence Score decreased from a mean of 17.5 (range, 14.0-20.0) to 7.3 (range, 0-12.0), and Fecal Incontinence Quality of Life scores improved in all of the domains. Bowel diary results showed that 76% of the patients with implants experienced a ≥50% reduction in the number of fecal incontinence episodes per week. Manometry at 6 months after implantation showed increased mean resting and squeeze pressures. LIMITATIONS: This study does not allow for comparison between surgical treatments and involves a limited number of patients. CONCLUSIONS: Magnetic sphincter augmentation shows consistent results for the treatment of severe fecal incontinence in this patient group. The surgical procedure is straightforward as compared with other implantable devices. The safety profile is acceptable. Magnetic sphincter augmentation is a promising new treatment with the potential to become a first-line surgical therapy for patients with severe fecal incontinence.
BACKGROUND: Fecal incontinence is a common, distressing condition with limited surgical options. OBJECTIVE: This study examines the results of magnetic sphincter augmentation in patients with severe fecal incontinence. DESIGN: This was a single-center, prospective, nonrandomized investigation. SETTING: This study was conducted in a private colorectal practice. PATIENTS: The cohort included all of the patients implanted with magnetic sphincter augmentation between January 2012 and October 2013. INTERVENTION: Magnetic sphincter augmentation was studied. MAIN OUTCOME MEASURES: Adverse events, symptom severity, quality of life, bowel diary, and manometry data were collected. RESULTS: Eighteen patients (15 women), with mean age of 69 years (range, 31-91 years), were implanted with magnetic sphincter augmentation. Follow-up ranged from 353 to 738 days. Previous treatment consisted of peripheral nerve evaluation test in 10 patients (56%), 2 patients (11%) with previous permanent sacral nerve stimulation, and 1 patient (6%) with previous implantation of an artificial bowel sphincter. Implantation was successful in 17 (94%) of 18 patients. Five patients (29%) had postoperative pain, and 5 patients (29%) had temporary swelling and erythema in both gluteal regions after the implantation. No devices were explanted during the follow-up. Cleveland Clinic Incontinence Score decreased from a mean of 17.5 (range, 14.0-20.0) to 7.3 (range, 0-12.0), and Fecal Incontinence Quality of Life scores improved in all of the domains. Bowel diary results showed that 76% of the patients with implants experienced a ≥50% reduction in the number of fecal incontinence episodes per week. Manometry at 6 months after implantation showed increased mean resting and squeeze pressures. LIMITATIONS: This study does not allow for comparison between surgical treatments and involves a limited number of patients. CONCLUSIONS: Magnetic sphincter augmentation shows consistent results for the treatment of severe fecal incontinence in this patient group. The surgical procedure is straightforward as compared with other implantable devices. The safety profile is acceptable. Magnetic sphincter augmentation is a promising new treatment with the potential to become a first-line surgical therapy for patients with severe fecal incontinence.
Authors: David G Jayne; Annabelle E Williams; Neil Corrigan; Julie Croft; Alison Pullan; Vicky Napp; Rachel Kelly; David Meads; Armando Vargas-Palacios; Adam Martin; Claire Hulme; Steven R Brown; Karen Nugent; Jen Lodge; David Protheroe; Sushil Maslekar; Andrew Clarke; Pasha Nisar; Julia M Brown Journal: Health Technol Assess Date: 2021-03 Impact factor: 4.014
Authors: Annabelle E Williams; Julie Croft; Vicky Napp; Neil Corrigan; Julia M Brown; Claire Hulme; Steven R Brown; Jen Lodge; David Protheroe; David G Jayne Journal: Int J Colorectal Dis Date: 2016-01-12 Impact factor: 2.571