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Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: A randomized controlled trial§

Authors

  • Esther Bols,

    Corresponding author
    1. Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands
    2. Centre for Evidence Based Physiotherapy, Maastricht University Medical Centre, Maastricht, The Netherlands
    • Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre, PO Box 616, 6200 MD Maastricht, The Netherlands.
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  • Bary Berghmans,

    1. Pelvic care Center Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Rob de Bie,

    1. Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands
    2. Centre for Evidence Based Physiotherapy, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Bas Govaert,

    1. Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Bart van Wunnik,

    1. Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Martijn Heymans,

    1. Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
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  • Erik Hendriks,

    1. Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands
    2. Centre for Evidence Based Physiotherapy, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Cor Baeten

    1. Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Linda Brubaker led the review process.

  • Conflict of interest: none.

  • §

    The study sponsor had no role in the study design, in the collection, analysis and interpretation data, in the writing of the report, and in the decision to submit the paper for publication.

Abstract

Aims

Fecal incontinence (FI) is embarrassing, resulting in poor quality of life. Rectal sensation may be more important than sphincter strength to relieve symptoms. A single-blind, randomized controlled trial among adults with FI compared the effectiveness of rectal balloon training (RBT) and pelvic floor muscle training (PFMT) versus PFMT alone.

Methods

We randomized 80 patients, recruited from the Maastricht University Medical Centre. Primary outcome was based on the Vaizey score. Secondary outcomes were the Fecal Incontinence Quality of Life Scale (FIQL), 9-point global perceived effect (GPE) score, anorectal manometry, rectal distension volumes, and thresholds of anorectal sensation. Analyses were by intention-to-treat.

Results

Forty patients were assigned to combined RBT with PFMT and 40 to PFMT alone. Adding RBT did not result in a significant improvement in the Vaizey score [mean difference: −1.19; 95% confidence interval (CI): −3.79 to 1.42; P = 0.37]. Secondary outcomes favoring RBT were: Lifestyle subscale of the FIQL (0.37; 95% CI: 0.02–0.73; P = 0.04), GPE (−1.01; 95% CI: −1.75 to −0.27; P = 0.008), maximum tolerable volume (49.35; 95% CI: 13.26–85.44; P = 0.009), and external anal sphincter fatigue (0.65; 95% CI: 0.26–1.04; P = 0.001). Overall, 50% of patients were considered improved according to the estimated minimally important change (Vaizey change ≥−5).

Conclusions

RBT with PFMT was equally effective as PFMT alone. Secondary outcomes show beneficial effects of RBT on urgency control, GPE, and lifestyle adaptations. Characteristics of patients who benefit most from RBT remain to be confirmed. Neurourol. Urodynam. 31:132–138, 2012. © 2011 Wiley Periodicals, Inc.

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