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Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-control Treatment in Adults with Fecal Incontinence

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@article{e47ea8b4fcf2412da85374b0912bc84e,
title = "Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-control Treatment in Adults with Fecal Incontinence",
abstract = "Background & Aims: Pelvic floor muscle training (PFMT) in combination with conservative treatment is recommended as first-line treatment for patients with fecal incontinence, although its efficacy is unclear. We investigated whether supervised PFMT in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in adults with fecal incontinence. Methods: We performed a randomized, controlled, superiority trial of patients with fecal incontinence at a tertiary care center at a public hospital in Denmark. Ninety-eight adults with fecal incontinence were randomly assigned to groups that received supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment. The primary outcome was rating of symptom changes, after 16 weeks, based on scores from the Patient Global Impression of Improvement scale. Secondary outcomes were changes in the Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale. Results: In the intention-to-treat analysis, participants in the PFMT group were significantly more likely to report improvement in incontinence symptoms based on Patient Global Impression of Improvement scale scores (unadjusted odds ratio, 5.16; 95{\%} CI, 2.18–12.19; P = .0002). The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95{\%} CI, –3.57 to –0.08; P = .04). There were no significant differences in condition-specific quality of life. In the per-protocol analyses, the superiority of PFMT was increased. No adverse events were reported. Conclusions: This randomized controlled trial of adults with fecal incontinence provides support for a superior effect of supervised PFMT in combination with conservative treatment compared with attention-control massage treatment and conservative treatment. We found that participants who received supervised PFMT had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean reduction of incontinence severity based on the Vaizey Score compared with attention control massage treatment. Clinicaltrials.gov no: NCT01705535.",
keywords = "Attention-Control Treatment, Biofeedback, Fecal Incontinence, Pelvic Floor Muscle Training, Physical Therapy Modalities, Physiotherapy",
author = "Anja Ussing and Inge Dahn and Ulla Due and Michael S{\o}rensen and Janne Petersen and Thomas Bandholm",
note = "Copyright {\circledC} 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.",
year = "2019",
month = "10",
doi = "10.1016/j.cgh.2018.12.015",
language = "English",
volume = "17",
pages = "2253--2261.e4",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B./Saunders Co",
number = "11",

}

RIS

TY - JOUR

T1 - Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-control Treatment in Adults with Fecal Incontinence

AU - Ussing, Anja

AU - Dahn, Inge

AU - Due, Ulla

AU - Sørensen, Michael

AU - Petersen, Janne

AU - Bandholm, Thomas

N1 - Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.

PY - 2019/10

Y1 - 2019/10

N2 - Background & Aims: Pelvic floor muscle training (PFMT) in combination with conservative treatment is recommended as first-line treatment for patients with fecal incontinence, although its efficacy is unclear. We investigated whether supervised PFMT in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in adults with fecal incontinence. Methods: We performed a randomized, controlled, superiority trial of patients with fecal incontinence at a tertiary care center at a public hospital in Denmark. Ninety-eight adults with fecal incontinence were randomly assigned to groups that received supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment. The primary outcome was rating of symptom changes, after 16 weeks, based on scores from the Patient Global Impression of Improvement scale. Secondary outcomes were changes in the Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale. Results: In the intention-to-treat analysis, participants in the PFMT group were significantly more likely to report improvement in incontinence symptoms based on Patient Global Impression of Improvement scale scores (unadjusted odds ratio, 5.16; 95% CI, 2.18–12.19; P = .0002). The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95% CI, –3.57 to –0.08; P = .04). There were no significant differences in condition-specific quality of life. In the per-protocol analyses, the superiority of PFMT was increased. No adverse events were reported. Conclusions: This randomized controlled trial of adults with fecal incontinence provides support for a superior effect of supervised PFMT in combination with conservative treatment compared with attention-control massage treatment and conservative treatment. We found that participants who received supervised PFMT had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean reduction of incontinence severity based on the Vaizey Score compared with attention control massage treatment. Clinicaltrials.gov no: NCT01705535.

AB - Background & Aims: Pelvic floor muscle training (PFMT) in combination with conservative treatment is recommended as first-line treatment for patients with fecal incontinence, although its efficacy is unclear. We investigated whether supervised PFMT in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in adults with fecal incontinence. Methods: We performed a randomized, controlled, superiority trial of patients with fecal incontinence at a tertiary care center at a public hospital in Denmark. Ninety-eight adults with fecal incontinence were randomly assigned to groups that received supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment. The primary outcome was rating of symptom changes, after 16 weeks, based on scores from the Patient Global Impression of Improvement scale. Secondary outcomes were changes in the Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale. Results: In the intention-to-treat analysis, participants in the PFMT group were significantly more likely to report improvement in incontinence symptoms based on Patient Global Impression of Improvement scale scores (unadjusted odds ratio, 5.16; 95% CI, 2.18–12.19; P = .0002). The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95% CI, –3.57 to –0.08; P = .04). There were no significant differences in condition-specific quality of life. In the per-protocol analyses, the superiority of PFMT was increased. No adverse events were reported. Conclusions: This randomized controlled trial of adults with fecal incontinence provides support for a superior effect of supervised PFMT in combination with conservative treatment compared with attention-control massage treatment and conservative treatment. We found that participants who received supervised PFMT had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean reduction of incontinence severity based on the Vaizey Score compared with attention control massage treatment. Clinicaltrials.gov no: NCT01705535.

KW - Attention-Control Treatment

KW - Biofeedback

KW - Fecal Incontinence

KW - Pelvic Floor Muscle Training

KW - Physical Therapy Modalities

KW - Physiotherapy

UR - http://www.scopus.com/inward/record.url?scp=85071125215&partnerID=8YFLogxK

U2 - 10.1016/j.cgh.2018.12.015

DO - 10.1016/j.cgh.2018.12.015

M3 - Journal article

VL - 17

SP - 2253-2261.e4

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

SN - 1542-3565

IS - 11

ER -

ID: 55904236