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

E. Bols, B. Berghmans, R. van der Bie, B. Govaert, B. van Wunnik, M. Heymans, E. Hendriks, C. Baeten

Research output: Contribution to journalArticleAcademicpeer-review

11 Citations (Scopus)

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. (c) 2011 Wiley Periodicals, Inc.
Original languageEnglish
Pages (from-to)132-138
Number of pages7
JournalNeurourology and Urodynamics
Volume31
Issue number1
DOIs
Publication statusPublished - 1 Jan 2012

Keywords

  • biofeedback
  • fecal incontinence
  • pelvic floor
  • physical therapy
  • Vaizey score
  • MULTIPLE IMPUTATION
  • BIOFEEDBACK THERAPY
  • URINARY

Cite this

Bols, E. ; Berghmans, B. ; van der Bie, R. ; Govaert, B. ; van Wunnik, B. ; Heymans, M. ; Hendriks, E. ; Baeten, C. / Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: A randomized controlled trial. In: Neurourology and Urodynamics. 2012 ; Vol. 31, No. 1. pp. 132-138.
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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. (c) 2011 Wiley Periodicals, Inc.",
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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. / Bols, E.; Berghmans, B.; van der Bie, R.; Govaert, B.; van Wunnik, B.; Heymans, M.; Hendriks, E.; Baeten, C.

In: Neurourology and Urodynamics, Vol. 31, No. 1, 01.01.2012, p. 132-138.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: A randomized controlled trial

AU - Bols, E.

AU - Berghmans, B.

AU - van der Bie, R.

AU - Govaert, B.

AU - van Wunnik, B.

AU - Heymans, M.

AU - Hendriks, E.

AU - Baeten, C.

PY - 2012/1/1

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N2 - 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. (c) 2011 Wiley Periodicals, Inc.

AB - 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. (c) 2011 Wiley Periodicals, Inc.

KW - biofeedback

KW - fecal incontinence

KW - pelvic floor

KW - physical therapy

KW - Vaizey score

KW - MULTIPLE IMPUTATION

KW - BIOFEEDBACK THERAPY

KW - URINARY

U2 - 10.1002/nau.21218

DO - 10.1002/nau.21218

M3 - Article

VL - 31

SP - 132

EP - 138

JO - Neurourology and Urodynamics

JF - Neurourology and Urodynamics

SN - 0733-2467

IS - 1

ER -