Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: a randomized controlled trial.
ABSTRACT 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.
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.
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).
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.
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ABSTRACT: Biofeedback is a nonsurgical treatment that reportedly produces good results in 65-75% of fecally incontinent patients. However, previous studies have not ruled out nonspecific treatment effects. It is also unknown whether biofeedback works primarily by improving the strength of the striated pelvic floor muscles or by improving the rectal perception. We aimed to 1) evaluate the efficacy of biofeedback in formed-stool fecal incontinence, 2) assess the relative contribution of sensory and strength retraining to biofeedback outcomes, and 3) identify patient characteristics that predict a good response to treatment. Twenty-four patients with frequent (at least once a week) solid-stool incontinence were provided with three to four biofeedback sessions. They were taught to squeeze in response to progressively weaker rectal distentions. Patients were re-evaluated by anorectal manometry and symptom diary 3 months after completing training and by diary and interview 6-12 months after training. Seventeen (71%) were classified responders; 13 became continent and four reduced incontinence frequency by at least 75%. Clinical improvements were maintained at 12-month follow-up. At 3-month follow-up, responders had significantly lower thresholds for perception of rectal distention and for sphincter contraction, but squeeze pressures did not significantly differ from those of nonresponders. Baseline measures that predicted a favorable response were sensory threshold (50 ml or less), urge threshold (100 ml or less), lower threshold for sphincter contraction, and lower threshold for the rectoanal inhibitory reflex; neither anal squeeze pressure nor severity of incontinence predicted treatment outcome. In solid-stool fecal incontinence biofeedback training effects are robust and seem not to be explained by expectancy or nonspecific treatment effect. Sensory retraining appears to be more relevant than strength training to the success of biofeedback.The American Journal of Gastroenterology 02/2002; 97(1):109-17. · 7.55 Impact Factor
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ABSTRACT: Various outcome measures exist to evaluate treatment in fecal incontinence, including descriptive, severity (fecal incontinence scoring systems), and impact (quality-of-life questionnaires) and diagnostic measures. We studied associations between changes after treatment for a number of outcome measures and compared them to patients' subjective perception of relief. We analyzed data of 66 patients (92 percent female; mean age, 62 years) (Vaizey score, Wexner score, two impact scales, utility, resting pressure, and maximal incremental squeeze pressure) at baseline and after physiotherapy. In a standardized interview by phone, we asked patients to compare their situation before and after treatment. Correlations between changes in outcome measures were calculated. These changes were compared with patients' subjective perception. There was a high correlation between the changes in the Vaizey and the Wexner scores (r = 0.94, P < 0.01). Changes in Vaizey and Wexner scores correlated moderately with changes in maximum incremental squeeze pressure (r = -0.29, -0.30, both P < 0.05). Changes in utility and resting pressure were not correlated with changes in any of the other measurements (all r values between -0.086 and 0.18). Average severity scores (Vaizey and Wexner) were 1 point lower for patients who rated their situation as worse or equal (62 percent), 4 points lower for patients who reported their situation to be better (21 percent), and 9 points lower in patients who rated their situation much better (17 percent) (P < .05). Severity measures are best related to patients' subjective perception of relief.Diseases of the Colon & Rectum 12/2005; 48(12):2294-301. · 3.34 Impact Factor
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ABSTRACT: We examine the collected evidence for efficacy of biofeedback therapy (BFT) in incontinence and constipation by means of meta-analysis of randomized controlled trials. PubMed search was performed to identify treatment trials that match quality criteria (adequate control groups, randomization). They were entered into meta-analyses using fixed effect models and computing odds ratio (OR) and 95% confidence interval (CI) of treatment effects. For constipation, eight BFT trials were identified. In four trials, electromyographic (EMG) BFT was compared to non-BFT treatments (laxatives, placebo, sham training and botox injection), while in the remaining four studies EMG BFT was compared to other BFT (balloon pressure, verbal feedback) modes. Meta-analyses revealed superiority of BFT to non-BFT (OR: 3.657; 95% CI: 2.127-6.290, P < 0.001) but equal efficacy of EMG BFT to other BF applications (OR: 1.436; CI: 0.692-3.089; P = 0.319). For fecal incontinence, a total of 11 trials were identified, of which six compared BFT to other treatment options (sensory training, pelvic floor exercise and electrical stimulation) and five compared one BFT option to other modalities of BFT. BFT was equal effective than non-BFT therapy (OR: 1.189, CI: 0.689-2.051, P = 0.535). No difference was found when various modes BFT were compared (OR: 1.278, CI: 0.736-2.220, P = 0.384). Included trials showed a substantial lack of quality and harmonization, e.g. variable endpoints and missing psychological assessment across studies. BFT for pelvic floor dyssynergia shows substantial specific therapeutic effect while BFT for incontinence is still lacking evidence for efficacy. However, in both conditions the mode of BFT seems to play a minor role.Neurogastroenterology and Motility 07/2009; 21(11):1133-41. · 2.94 Impact Factor
PELVIC PHYSIOTHERAPY IN
Pelvic physiotherapy in faecal incontinence
Esther M.J. Bols
ISBN: 978 94 6159 050 3
Cover design: Mischa Visser
Lay‐out: Yvonne Leenders
Printed by: Datawyse ‐ Universitaire Pers Maastricht
© Copyright E.M.J. Bols, Maastricht 2011
All rights reserved. No part of this thesis may be reproduced or transmitted in any form
or by any means, electronic or mechanical, including photocopying, recording or any
information storage or retrieval system, without permission in writing from the author,
or, when appropriate, from the publishers of the publications.
Pelvic physiotherapy in faecal incontinence
Ter verkrijging van de graad van doctor
aan de Universiteit Maastricht,
op gezag van de Rector Magnificus,
Prof. mr. G.P.M.F. Mols,
volgens het besluit van het College van Decanen,
in het openbaar te verdedigen
op woensdag 15 juni 2011 om 14:00 uur
Esther Maria Johanna Bols
Prof. dr. R.A. de Bie
Dr. L.C.M. Berghmans
Dr. H.J.M. Hendriks
Prof. dr. A.A.M. Masclee (voorzitter)
Dr. R.J.F. Felt‐Bersma (VUMC Amsterdam)
Dr. G.A. van Koeveringe
Prof. dr. S. Mørkved (Norwegian University of Science and Technology,
Prof. dr. M.H. Prins
This project was embedded in CAPHRI, the School for Public Health and
Primary Care, Maastricht University.
The studies presented in this thesis were conducted at the Department
of Epidemiology, CAPHRI, the School for Public Health and Primary Care,
Maastricht University. CAPHRI is part of the Netherlands School of Pri‐
mary Care Research (CaRe), which has been acknowledged since 1995
by the Royal Netherlands Academy of Arts and Sciences (KNAW).
Financial support by the Dutch Association for Physical Therapy for
Pelvic Floor Disorders and Pre‐ and Postnatal Healthcare (NVFB) and the
Royal Dutch Society for Physical Therapy (KNGF) for the publication of
this thesis is gratefully acknowledged.
Financial support for the printing of this thesis was kindly provided by
the Department of Epidemiology (Maastricht University).
‘Life is like a box of chocolates...you never know what you're gonna get!’
Aan mijn lieve ouders,
General introduction and outline of the thesis 9
Physiotherapy and surgery in faecal incontinence: an overview 17
A systematic review of aetiological factors for postpartum faecal
Inconclusive psychometric properties of the Vaizey score in
faecally incontinent patients: a prospective cohort study
A randomised physiotherapy trial in patients with faecal
incontinence: design of the PhysioFIT‐study
Rectal balloon training as add‐on therapy to pelvic floor
muscle training in adults with faecal incontinence:
a randomised controlled trial
Predictors of a favourable outcome of physiotherapy in faecal
incontinence: secondary analysis of a randomised trial
A critical evaluation of the Vaizey score, Wexner score and the
Fecal Incontinence Quality of Life Scale for clinical use in
patients with faecal incontinence
General discussion 187
Curriculum vitae 223
GENERAL INTRODUCTION AND OUTLINE OF
‘Je Zal Het Maar Hebben’ (‘What if it happened to you?’) is a Dutch television
programme which vividly discusses several disorders that are extremely embarrassing,
may cause withdrawal from social activities and reduce quality of life. When the sub‐
ject of ‘faecal incontinence’ was discussed, the presenter was standing in a sewerage
system (BNN, episode ‘Shit happens’, July 21, 2003).
I have frequently found that many people do not know what faecal incontinence is, or
are unaware how many people are affected by it. Faecal incontinence is the complaint
of involuntary loss of faeces (including liquid and solid stools).1 Anal incontinence is
mostly used to include faeces or flatus. Terms like ‘the unvoiced symptom’ or ‘the
silent affliction’ typically describe and illustrate the enormous embarrassment felt by
patients affected by it.2 As was illustrated by the location where the TV presenter was
standing, faecal incontinence is associated with negative concepts like dirt, disgust and
smelliness. Figures on help‐seeking behaviour confirm the idea of suffering in silence,
since they show that only one third of patients have the courage to consult a
physician.3 The reasons for not seeking help are unclear but may relate to social class,
mild symptoms, lack of bother or embarrassment, or a perceived lack of effective
treatment. Cross‐sectional studies have shown that about 0.4–18% of people suffer
from faecal incontinence (incontinence for liquid and solid stools), although these
rates are likely to be underestimated.4,5 Coping techniques used by patients include
the use of incontinence absorption materials, never straying far from a toilet, avoiding
social contacts, only leaving home after defecation, using perfume to disguise bad
smells and making noises at moments they expect to lose gas or stool. From this per‐
spective, there is enough reason to characterise faecal incontinence as an example of
the kind of embarrassing disorders featured in the ‘What if it happened to you’
The ageing of the population will make faecal incontinence an increasingly important
socioeconomic problem in the coming decades, especially since it leads to reduced
quality of life and premature institutionalisation, which has important cost implica‐
tions.6 It is not, as is often incorrectly thought, only elderly and/or institutionalised
people who are affected. Younger people are affected as well, especially postpartum
women with obstetric risk. However, conflicting results about the contributions of
maternal, obstetric and foetal characteristics to postpartum faecal incontinence
hamper the prevention and management of this problem.
There are numerous methods to treat patients with faecal incontinence, which can be
classified as non‐surgical or surgical. Mild incontinence is mostly treated successfully
with conservative methods like constipating medication, dietary changes, lifestyle ad‐
vice or toilet behaviour. If these fail, or in the case of more severe faecal incontinence,
the next option is usually pelvic physiotherapy, and failure of pelvic physiotherapy is
then often a criterion for proceeding to surgical management.7 Depending on the un‐
derlying cause and severity, surgical treatment may offer equal or sometimes greater
benefit, but also involves a greater risk of complications.
Pelvic physiotherapy was first introduced in the 1970s and is regarded as safe, inex-
pensive and well-tolerated.8,9 The first publications reported on the use of biofeedback
(element of pelvic physiotherapy), and these were followed by the first randomised
clinical trial, published in 1984.10 Since then, about 16 randomised clinical trials have
studied the effects of pelvic physiotherapy for faecal incontinence, the majority having
been done after 2000.11-26 The differences between these trials in terms of study
methods, patient groups, duration of follow-up, and methodological weaknesses ham-
per the interpretation of the findings.27 In particular, no decisive conclusions have
been drawn about the effectiveness of different methods of biofeedback, the use of
biofeedback compared with exercises alone, or biofeedback combined with other
interventions.7,28,29 The lack of high-quality research in the field of pelvic physiotherapy
may have several consequences. First, insurance companies or other third-party health
care funders do not reimburse physiotherapy treatment for patients with faecal incon-
tinence, because it remains unproven whether it is effective and cost-effective, and
this may limit access to valuable treatment. Second, referring physicians need to keep
abreast of the options offered by physiotherapeutic diagnostics and intervention. Lack
of recommendations indicating which elements of pelvic physiotherapy treatment are
effective hampers early clinical decision-making, efficient use of resources, efficient
referral and adequate cooperation between physicians and physiotherapists. In view of
the lack of knowledge about effective modalities of physiotherapy treatment in faecal
incontinence, we undertook a randomised controlled trial which included adult pa-
tients who had had moderate to severe faecal incontinence complaints for at least six
The design of studies evaluating effectiveness of treatment of faecal incontinence is
problematic as no well-validated outcome measures are available. Frequently used
outcome measures to evaluate the severity of faecal incontinence and the quality of
life of the patients, such as the Vaizey score, Wexner score, and Fecal Incontinence
Quality of Life Scale, have not been thoroughly evaluated in terms of several psycho-
metric properties. In particular, there is a lack of information on the clinically meaning-
ful interpretation of changes in the outcomes. This field needs further exploration in
order to optimise sample size calculations, evaluation and interpretation of outcomes.
Finally, patient selection on the basis of predictive factors will help to improve the
management of patients with faecal incontinence. So far, it is unclear which patients
are likely to benefit from physiotherapy treatment, which is relevant for medical
decision making and patient counselling. Therefore, we aimed to identify patient
characteristics predicting a favourable outcome of pelvic physiotherapy treatment.
AIM AND OUTLINE OF THE THESIS
The aim of this thesis is to present new evidence concerning different aspects of the
management of patients with faecal incontinence, in order to enable physicians and
physiotherapists to provide competent individual counselling and treatment to all
patients who suffer from it. Although interest in the subject of faecal incontinence has
increased in recent years, there is still a long way to go to optimise the diagnostic and
treatment process for these patients. The aim of the work summarised in this thesis
was (1) to examine the state of the art for various aspects of the management of pa-
tients with faecal incontinence, (2) to evaluate which delivery-related factors are
important in the development of faecal incontinence in a frequently affected young
patient group, i.e. postpartum women, (3) to assess psychometric properties and mini-
mally important change for the Vaizey score, Wexner score and Fecal Incontinence
Quality of Life Scale for clinical use in patients with faecal incontinence, (4) to assess
the effect of adding rectal balloon training to pelvic floor muscle training in patients
with faecal incontinence, and (5) to identify patient characteristics predicting a favour-
able outcome of physiotherapy treatment.
Chapter 2 presents a survey of the state of the art. Its aim is to give an overview of
aetiological factors for faecal incontinence, the diagnostic work-up, reported outcome
measures and the conservative and surgical treatment options for faecally incontinent
patients, including their effectiveness.
The literature review shows that vaginal delivery has been identified as one of the
major causes of faecal incontinence in young women. Delivery may be followed by
sphincter defects and/or pudendal neuropathy due to excessive straining. Many
women present with faecal incontinence symptoms immediately after delivery or later
in life, presumably because the cumulative effects of multiple deliveries, progressive
neuropathy, ageing and the menopause are too much for the compensatory mecha-
nisms. The literature overview yielded no definitive conclusions as to which maternal,
obstetric or foetal characteristics contributed most to postpartum faecal incontinence.
Chapter 3 therefore presents the results of a systematic review to assess the aetiolo-
gical factors for postpartum faecal incontinence.
The literature review also showed that several multi-item scoring systems have
emerged, the Vaizey score being a frequently reported outcome. So far, inconclusive
results have been presented on the psychometric properties for evaluative purposes
following physiotherapy treatment. Accordingly, chapter 4 explores the psychometric
properties of the Vaizey score, giving special attention to the minimally important
The next two chapters describe a randomised controlled trial assessing the effective-
ness of rectal balloon training combined with pelvic floor muscle training, compared to
pelvic floor muscle training alone in patients with faecal incontinence. Chapter 5
describes the design of the randomised controlled trial, while chapter 6 presents its
results in terms of short‐term effectiveness of rectal balloon training as an add‐on
therapy to pelvic floor muscle training.
The remaining chapters report on secondary analyses of data from the randomised
controlled trial. Chapter 7 addresses the baseline characteristics which are important
in predicting a favourable or unfavourable outcome of physiotherapy treatment in
patients with faecal incontinence, while chapter 8 critically evaluates the Vaizey score,
Wexner score and Fecal Incontinence Quality of Life Scale for clinical use in these
patients. The results of the psychometric evaluation as well as estimates of the
minimally important change are presented.
Finally, chapter 9 summarises the main findings reported in this thesis, and discusses
methodological aspects of the different studies, as well as implications for clinical prac‐
tice and for future research.
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