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Randomized Pilot Study: Anal Inserts Versus Percutaneous Tibial Nerve Stimulation in Patients With Fecal Incontinence
Cosimo Alex Leo1,2,3, Gregory P Thomas1, Jonathan D Hodgkinson1,2
1Department of Surgery, St Mark's Hospital and Academic Institute, London, United Kingdom.
Diseases of the Colon and Rectum
|January 5, 2021
Summary
Anal inserts were more effective than percutaneous tibial nerve stimulation (PTNS) in treating fecal incontinence. Both treatments improved symptoms, but anal inserts achieved a greater reduction in episodes for patients with fecal incontinence.
Area of Science:
- Gastroenterology and Clinical Medicine
- Pelvic Floor Disorders
- Nerve Stimulation Therapies
Background:
- Fecal incontinence (FI) significantly impacts quality of life.
- Anal inserts and percutaneous tibial nerve stimulation (PTNS) are conservative treatment options for FI.
- Limited comparative data exists for these two interventions.
Purpose of the Study:
- To compare the efficacy of anal inserts versus PTNS in patients with fecal incontinence.
- To evaluate symptom improvement and patient-reported outcomes.
Main Methods:
- Investigator-blinded, randomized pilot study.
- 50 adult patients with passive or mixed FI were randomized.
- Interventions: Anal inserts or weekly PTNS for 3 months.
- Primary outcome: ≥50% reduction in weekly FI episodes (bowel diary).
- Secondary outcomes: St. Mark's incontinence score, ICIQ-B scores, antidiarrheal use, comfort, and acceptability.
Main Results:
- Both groups showed significant improvement in FI symptoms and quality of life scores.
- Anal inserts achieved a ≥50% reduction in FI episodes in 76% of patients, compared to 48% for PTNS (p=0.04).
- St. Mark's and ICIQ-B scores indicated similar improvements in bowel pattern, control, and quality of life for both groups (p=0.01).
Conclusions:
- Both anal inserts and PTNS are effective in improving fecal incontinence symptoms.
- Anal inserts demonstrated superior efficacy in reducing FI episodes compared to PTNS in this pilot study.
- Larger randomized controlled trials are warranted to confirm these findings and further investigate the comparative effectiveness of these treatments.
