Trial reportDeutsches Arzteblatt international2011
Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial.
Trial report in Deutsches Arzteblatt international, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review.United European gastroenterology journal · 2020Pooled it
- Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review.International journal of colorectal disease · 2013Pooled it
- Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults.The Cochrane database of systematic reviews · 2012Pooled it
- Home electrical stimulation for women with fecal incontinence: a preliminary randomized controlled trial.International journal of colorectal disease · 2015Trial
- The Japan Society of Coloproctology Practice Guidelines for Fecal Incontinence 2024 (Revised Second Edition).Journal of the anus, rectum and colon · 2026Review
- The Clinical Utility of Anorectal Manometry: A Review of Current Practices.Gastro hep advances · 2025Review
- Study on the treatment of dysphagia after stroke with electromyographic biofeedback intensive training.World journal of clinical cases · 2024Article
- Diagnosis and Treatment of Obstetric Anal Sphincter Injuries: New Evidence and Perspectives.Journal of clinical medicine · 2021Review
- Pelvic floor rehabilitation for defecation disorders.Techniques in coloproctology · 2019Review
- Endpoints for therapeutic interventions in faecal incontinence: small step or game changer.Neurogastroenterology and motility · 2016Review
- Treatment of fecal incontinence: state of the science summary for the National Institute of Diabetes and Digestive and Kidney Diseases workshop.The American journal of gastroenterology · 2015Article
- Pelvic floor rehabilitation in the treatment of fecal incontinence.Clinics in colon and rectal surgery · 2014Review
- Technique of functional and motility test: how to perform biofeedback for constipation and fecal incontinence.Journal of neurogastroenterology and motility · 2013Article
- [Pelvic floor and anal incontinence. Conservative therapy].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2013Review
- Alternative approaches to the treatment of fecal incontinence.Deutsches Arzteblatt international · 2011Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the nonsurgical treatment of anal incontinence, the combination of amplitude-modulated medium-frequency stimulation and electromyographic biofeedback (EMG-BF), known as triple-target treatment (3T), is superior to EMG-BF alone. The aim of this trial is to compare 3T with the standard treatment, low-frequency stimulation (LFS).
methods80 patients with anal incontinence of Grade I or higher who presented to physicians or centers specialized in coloproctology were enrolled in this multicenter randomized trial with blinded observer. The trial had an open parallel-group design. Randomization was performed centrally by telephone. The primary endpoint was the Cleveland Clinic Score (CCS) after self-training at home with either 3T or LFS in two 20-minute sessions per day for 6 months. The secondary endpoints included the proportion of patients regaining continence, and the patients' quality of life (QoL). On completion of the trial as planned, the results were evaluated with an intention-to-treat analysis. STUDY REGISTRATION: DRKS00000138 (http://register.germanctr.de).
results39 patients were randomized to 3T, and 41 to LFS. After 6 months of treatment, the CCS (mean ± standard deviation) was 3.1 ± 4.2 in the 3T group and 9.6 ± 3.9 in the LFS group. The median improvement in the CCS at 6 months compared to baseline was 7 points greater in the 3T group than in the LFS group (95% CI: 5-9, p<0.001). Anal continence was regained by 54% of the 3T patients, but none of the LFS patients (95% CI for the difference: 37.18% - 69.91%, p<0.001). QoL scores were higher in all dimensions in the 3T group than in the LFS group. No major adverse effects occurred in either group.
conclusion3T is superior to LFS in the treatment of anal incontinence. The available evidence suggests that the success of 3T is based on the combined effect of biofeedback and medium-frequency stimulation. LFS of the type applied in this trial has no effect. 3T should be used in routine clinical practice instead of LFS.
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