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Stress Urinary
Incontinence Cure |
Pelvic Floor
Muscle
Training and Adjunctive Therapies for the Treatment
of Stress Urinary Incontinence in Women: a
Systematic Review
Patricia B Neumann1, Karen A Grimmer2
and Yamini Deenadayalan3 : 1PhD
candidate, School of Health Sciences, University of
South Australia, Adelaide, Australia, 2Director,
Centre for Allied Health Evidence, University of
South Australia, Adelaide, Australia, 3Research
Assistant, Centre for Allied Health Evidence,
University of South Australia, Adelaide, Australia BMC Women's Health 2006,
6:11 doi:10.1186/1472-6874-6-11
� 2006 Neumann et al; licensee BioMed Central Ltd.:
This is an Open Access article distributed under the
terms of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
work is properly cited. |
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Stress Urinary
Incontinence Treatment study Abstract
Background of Stress Urinary Incontinence
Treatment study
|
Methods of Stress Urinary Incontinence
Treatment study
Type of Outcome Measures of the Urinary
Incontinence Treatment study |
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Assessment of
methodological quality
Level of evidence
The level of evidence of each retrieved study was
assessed using the Australian National Health &
Medical Research Council [24]
levels of evidence [see
additional file 3] in order to describe
potential for bias.
Methodological
quality
To evaluate the methodological quality of the
included studies for urinary incontinence
treatments, each study was critically
appraised by two independent reviewers using a
purpose-built critical review instrument [see
additional files 4 &
5].
The purpose-built instrument was a modification of
the tool developed by the McMaster University
Occupational Therapy Evidence-Based Practice
Research Group [30]. This
appraisal tool is a critical review form for
quantitative studies considering eight main points:
study purpose, literature, study design, sample,
outcomes, intervention, results, conclusions and
clinical implications. Although this tool was
designed for all types of quantitative studies,
other authors have recommended a separate tool for
each of the two main types of design: experimental
and observational studies [31].
We developed our tools drawing on information from
the Agency for Healthcare Research and Quality
report 'Systems to Rate the Strength of Scientific
Evidence' [31] and from the
Centre for Reviews and Dissemination, University of
York [21]. The modified tool
developed for this review provides a maximum quality
rating score of 23 for RCTs and a maximum score of
19 for non-RCTs. It was pilot-tested and modified a
number of times before implementation to ensure
content and face validity, and agreement on its
application by the reviewers involved in this
review. The final version of the purpose-built
instrument was then applied by two reviewers working
independently. They then compared critical appraisal
scores and resolved disagreements in scoring by
discussion.
Details of the quality
assessment are provided [see
additional files 4 & 5]
with studies ranked according to their quality
assessment score to provide readers with an overview
of their methodological quality. All the studies
were then considered for the strength of their
evidence, based on the quality score and with
particular consideration of the factors which were
concerned with control of bias. Studies with a high
quality score were considered to show evidence of
good control of bias (eg attention to random
allocation processes, baseline similarity of groups,
reliable outcome measures) as well as other factors
concerning quality reporting, such as consideration
of ethical processes and relevance of the literature
review. Studies with a high quality score are
identified and highlighted by the reviewers in the
text for their contribution to evidence about
treatment outcomes.
Data extraction
Relevant data was extracted from each study in a
separate extraction sheet, providing a profile of
each study using the following headings:
-
Information about service delivery (health
professional and setting/institution)
-
Demographic information about the subjects in the
study
-
Study methods
-
Descriptions of the intervention(s)
-
Description of the outcome measure(s)
-
Key results from data analysis � short term and at
12 months
Similar to the process of critical appraisal, both
reviewers extracted information independently and
where there was disagreement, consensus was reached
by discussion or in consultation with a third party
Data synthesis
Because our review included studies of evidence
levels II, III and IV (NHMRC 1999), and because
study measures were not homogenous, it was not
possible to analyse the data by meta-analysis. Thus
findings are presented as narrative summaries. In
studies with a 'no treatment' or 'usual treatment'
control group, analysis of between-group effects
were reported in this analysis. In studies without a
control group, within-group changes were used to
calculate treatment effects. All relevant outcomes
ie those fitting the inclusion criteria, were
reported, including statistically significant and
non-significant findings.
Results
Methodological
Quality and Description of Studies
The search identified 7760 potentially relevant
research reports in the period 1995�2005, of which
24 studies fulfilled the inclusion criteria and
hence were considered in this review. Twenty one
included studies were English peer-reviewed research
reports, three were peer-reviewed conference
abstracts with no published full-text report and one
was a peer-reviewed foreign language paper with an
English language abstract. This English abstract was
used for data extraction. There was 100% agreement
between the reviewers in terms of study inclusion.
Summaries of the studies included in the review are
provided in Tables 1 and
2. Studies are presented in order of their
quality assessment score with information about the
level of evidence, interventions investigated and
information to determine the generalisability of the
study findings.
Arms of studies were excluded where there was no
description of a specific Pelvic Floor Muscle Training protocol. Thus the
following arm(s) were excluded: Cammu & van Nylen
(1997) [32] (VW only), Sung et al
(2000) [33] (ES/BF) and Bo et al
(1999) [34](ES, VW).
� Hierarchy of
Evidence
There was initially 91% agreement (Cohen's Kappa:
0.8) between the reviewers regarding the level of
evidence assigned to each study (NHMRC, 1999). A
Kappa score of more than 80% is considered to
represent 'excellent' agreement and between 60�80%
'substantial' agreement [35].
Complete agreement was reached after discussion.
Seventeen of the 24 studies identified were RCTs [32,34,36-50].
Seven were non-RCTs, of which three were level III-2
studies ie cohort or interrupted time series with a
control group [33,51,52]
and four were level IV studies ie case-series
(before-after investigations) without a control
group [53-56].
� Methodological
Quality of Included Studies
There was initially 83% agreement (Cohen's Kappa:
0.65) between the reviewers regarding the
methodological quality of the included studies.
After consultation, 100% agreement was reached. The
methodological quality of the studies was variable
with the highest scoring 100% (23/23) [34]
and the lowest (26%) 5/19 [55].
There was no correlation between a more recent date
of publication and quality score (Pearson's
correlation � 0.03, p > 0.05).
A summary of the quality assessment of the 17 level
II studies [see additional file
4] and the seven level III & IV
studies [see additional file 5] is provided. The
methodological quality of the RCTs varied from 23/23
(100%) [34] to 9/23 (39%) [36].
The methodological quality of the level III and IV
studies was also variable with scores from 14/19
(74%) [51] to 5/19 (26%) [55].
Studies with a lower quality score contained a
number of sources of bias which should be considered
when interpreting the results. However, the four
studies in abstract form had limited information for
quality assessment contributing to their lower
quality scores.
Types of
Participants
Women were included with a urodynamic diagnosis of
Stress Urinary Incontinence, a clinical diagnosis based on signs and/or
symptoms, or a combination of the above [1].
There was considerable variation in the hormonal
status and age (18�84 years) of subjects in this
review. Two studies [41,56]
specifically recruited younger, pre-menopausal women
with Stress Urinary Incontinence persisting at least 3 months after the last
childbirth. These authors stated that this time was
chosen to allow the hormonal changes from pregnancy
and parturition to have resolved. Another study [49]
also specifically recruited pre-menopausal women. By
contrast, Miller et al (1998) recruited older women
with a mean age of 68 (range 60�84) and Aksac et al
(2003) reported on women with a mean age of 53 (SD
7.2) years who were all using oral
hormone
replacement therapy. All other studies investigated
various combinations of Pelvic Floor Muscle Training and adjunctive
therapies in women with a mean age 46�56 (range of
18�80). Some of these studies stated that their
populations included women who were both pre- and
post-menopausal [33,34,38,43,47,54].
There was therefore considerable heterogeneity in
the studies reviewed in terms of possible
confounding due to age and hormonal status.
Identification
and/or Control of Potential Confounders
The following confounding variables were controlled
by stratification in a number of studies: severity
of symptoms [34,38,41,47],
referral source [34,38,41,47]
and parity [34].
The initial severity of
incontinence was not always
reported and methods used to describe severity
varied considerably so that any comparisons should
be made with caution (Table 3). Two studies included women with a past
history of surgery for incontinence [45,51].
In twelve studies, it was stated that women were
excluded if they had prior surgery for incontinence
[34,38,41-43,46,47,49,50,52-54]
and it was not reported in nine other studies [32,33,36,37,39,40,44,48,56].
Recruitment methods varied across the included
publications, which potentially influenced subjects'
responses to intervention. In three studies, the
participants were volunteers who responded to
newspaper advertisements [47] or
from outpatient hospital populations [41,56].
In three studies, participants were both volunteers
and referred [34,43,44].
In ten other studies, they were referred by a
medical practitioner or recruited from a tertiary
institution clinic population [33,37,38,45,48-50,52-54]
and in the remaining studies the source was not
reported [32,36,39,40,42,46,51,55].
Types of
Interventions for Urinary Incontinence Treatments
The studies were divided into intervention
categories and results summarised according to the
different interventions reported: 14 studies
reported on Pelvic Floor Muscle Training alone (Table
4), 11 studies on PFMT with BF (Table
5), three studies on PFMT and ES (Table
6), two studies on Pelvic Floor Muscle Training and VW (Table
7), three studies on PFMT with BF and ES (Table
8), one study on PFMT, BF and VW, (Table
9), and one study on Pelvic Floor Muscle Training combined with ES, BF
and VW (Table 10). Details of the protocols for the
interventions for all studies are detailed in
Table 11.
�
Pelvic Floor
Muscle Training
Studies were described by the broad types of Pelvic Floor Muscle Training
which were employed, ie specific strength training
(inducing muscle hypertrophy) or skill training
(improving motor learning), and their exercise
dosage (frequency, intensity, duration of the
training programs and compliance) [10].
The effect of specifically activating or
de-activating the abdominal wall during PFMT was
investigated. While reducing abdominal muscle
activity has been advocated to isolate the PFM and
minimise intra-abdominal pressure (Laycock, 1994),
more recently a synergistic activity of the deep
abdominal muscles (transversus abdominis and lower
fibres of obliquus internus) and PFM has been
described [57-59]. Training of
the deep abdominal muscles as a treatment for
incontinence has been advocated [60]
but more recently disputed [10].
�
Biofeedback
Many different applications of biofeedback were
described. Vaginal applications of EMG (electromyography)
[32,36,38,41,42,50,51],
pressure devices [44,45,47,48,56]
or perineal ultrasound [49,53]
were described. Three studies applied surface EMG BF
on the surface of the abdominal wall as well to
indicate abdominal muscle activity [32,42,50].
The EMG electrodes were placed over the rectus
abdominis in one study [50] but
the placement was not specified in the other two
studies. Vaginal BF was used as a home treatment in
three studies [44,45,47],
as home and clinic treatment in one study [45]
and in the others it was used only at clinic visits.
One study [42] used additional
rectal pressure BF to monitor intra-abdominal
pressure.
Two studies used trans-perineal ultrasound to teach
a correct elevating contraction at the first clinic
visit [49,53]
and in one study ultrasound was repeated for Pelvic Floor Muscle Training on
two further occasions [49].
Another study [36] did not
provide clear details whether pressure BF was used
for teaching only or training as well.
�
Electrical
Stimulation
Electrical stimulation was used in seven studies in
different combinations of therapy. [33,39,45,51,52,54,56].
Three studies investigated PF/ES, four studies a
combination of PFMT/BF/ES, and one study a
combination of PFMT/ES/BF/VW. The application and
protocols varied considerably. Two studies used
interferential currents with externally applied
suction cups with clinic treatment [52,56].
The others used vaginal application either with home
stimulation [39,45]
or at clinic visits [45,54].
� Vaginal
Weights
Different types of vaginal weights were used varying
from 20 g to 100 g.
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Protocols required women
to perform activities of daily living while
retaining the weight in the vagina [37,49,51],
while one [37] required women to
perform 'gymnastics' in addition to routine daily
activities but no details of this activity or of
subjects' compliance were provided. In all three
studies women additionally performed a Pelvic Floor Muscle Training program.
Types
of Outcomes of Urinary Incontinence Treatment
Studies
The Outcomes of Urinary Incontinence
Treatment Studies
Discussion about the Result of the Stress Urinary
Incontinence Treatment Studies
Conclusion of the Stress Urinary Incontinence
Treatment Studies |
Resources
|
1. |
|
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier
P, Ulmsten U, van Kerrebroeck P, Victor A, Wein
A: The standardisation of terminology of
lower urinary tract function: report from the
Standardisation Sub-committee of the
International Continence Society.
Am J Obst Gynecol 2002, 187(1):116-126. |
|
|
|
Return to citation in text: [1]
|
| |
|
10. |
|
Bo K: Pelvic floor muscle training is
effective in treatment of female stress
urinary
incontinence, but how does it work?
Int Urogynecol J Pelvic Floor Dysfunct
2004, 15(2):76-84. |
|
|
|
Return to citation in text: [1]
[2] |
| |
|
21. |
|
Khan SK, Kleijnen J: Centre for Reviews and
Dissemination . |
|
|
|
Return to citation in text: [1]
|
| |
|
24. |
|
National Health and Medical Research Council:
A guide to the development, implementation and
evaluation of clinical practice guidelines. |
|
|
|
Return to citation in text: [1]
|
| |
|
30. |
|
Law M, Stewart D, Pollock N, Letts L, Bosch J,
Westmorland M: Critical review form for
quantitative studies.
McMaster University: Occupational Therapy
Evidence-Based Research Group. ; |
|
|
|
Return to citation in text: [1] |
| |
|
31. |
|
Agency for Healthcare Research and Quality:
Systems to rate the strength of scientific
evidence.
Evidence Report/Technology Assessment No.47; |
|
|
|
Return to citation in text: [1]
[2] |
| |
|
32. |
|
Cammu H, Van Nylen M: Pelvic floor exercises
versus vaginal weight cones in genuine stress
incontinence.
Eur J Obstet Gynecol Reprod Biol 1998,
77(1):89-93. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] |
| |
|
33. |
|
Sung MS, Choi YH, Back SH, Hong JY, Yoon H:
The effect of pelvic floor muscle exercises on
genuine
stress incontinence among korean women -
focussing on its effects on the quality of life.
Yonsei Medical Journal 2000, 41(2):237-251. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] |
| |
|
34. |
|
Bo K, Talseth T, Holme I: Single blind,
randomised controlled trial of pelvic floor
exercises, electrical stimulation, vaginal cones
and no treatment in management of genuine stress
incontinence in women.
British Medical Journal 1999, 318:487-493.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7]
[8] [9]
[10] |
| |
|
35. |
|
Landis JR, Koch GG: The measurement of
observer agreeement for categorical data.
Biometrics 1977, 33:159-174. |
|
|
|
Return to citation in text: [1] |
| |
|
36. |
|
Aksac B, Aki S, Karan A, Yalcin O, Isikoglu M,
Eskiyurt N: Biofeedback and pelvic floor
exercises for the rehabilitation of
urinary
stress incontinence.
Gynecol Obstet Invest 2003, 56:23-27.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] |
| |
|
37. |
|
Arvonen T, Fianu-Jonasson A, Tyni-Lenne R:
Effectiveness of two conservative modes of
physical therapy in women with urinary stress
incontinence.
Neurourol Urodyn 2000, 20:591-599.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
|
| |
|
38. |
|
Berghmans LCM, Frederiks CMA, de Bie RA, Weil
EHJ, Smeets LWH, van Waalwikjk van Doorn ESC,
Janknegt RA: Efficacy of biofeedback, when
included with pelvic floor muscle exercise
treatment, for genuine stress incontinence.
Neurourol Urodyn 1996, 15:37-52. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7]
|
| |
|
39. |
|
Bidmead J, Mantle J, Cardozo L, Hextall A, Boos
K: Home electrical stimulation in addition to
conventional pelvic floor exercises: a useful
adjunct or expensive distraction?
In Neurol Urodyn. Volume 68. ;
2002:372-3. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5] |
| |
|
40. |
|
Bo K, Talseth T, Vinsnes A: Randomized
controlled trial on the effect of pelvic floor
muscle training on the quality of life and
sexual problems in genuine stress incontinent women.
Acta Obstetricia Et Gynecologica Scandinavica
2000, 79:598-603. |
|
|
|
Return to citation in text: [1]
[2] [3] |
| |
|
41. |
|
Dumoulin C, Lemieux MC, Bourbonnais D, Gravel D,
Bravo G, Morin M: Physiotherapy for
persistent postnatal stress
urinary
incontinence: A randomised controlled trial.
Obstet Gynecol 2004, 104(3):504-510. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7] |
| |
|
42. |
|
Glavind K, Nohr SB, Walter S: Biofeedback and
physiotherapy versus physiotherapy alone in the
treatment of genuine stress urinary
incontinence.
Int Urogynecol J Pelvic Floor Dysfunct
1996, 7:339-343. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] |
| |
|
43. |
|
Hay-Smith EJC, Herbison GP, Wilson PD: Pelvic
floor muscle training for women with symptoms of
stress urinary incontinence: A randomised trial
comparing strengthening and motor relearning
approaches.
Neurourol Urodyn 2002, 68:371-372. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] |
| |
|
44. |
|
Johnson VY: Effects of submaximal exercise
protocol to recondition the pelvic floor
musculature.
Nursing Research 2001, 50(1):33-41.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5] |
| |
|
45. |
|
Knight S, Laycock J, Naylor D: Evaluation of
neuromuscular electrical stimulation in the
treatment of genuine stress incontinence.
Physiotherapy 1998, 84(2):61-71.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7]
[8] [9] |
| |
|
46. |
|
Miller JM, Ashton-Miller JA, DeLancey JO: A
pelvic muscle precontraction can reduce
cough-related urine loss in selected women with
mild Stress Urinary Incontinence.
Journal of the American Geriatrics Society
1998, 46(7):870-874. |
|
|
|
Return to citation in text: [1]
[2] [3] |
| |
|
47. |
|
Morkved S, Bo K, Fjortoft T: Effect of adding
biofeedback to pelvic floor muscle training to
treat urodynamic stress incontinence.
Obstetrics & Gynecology 2002, 100(4):730-739.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7]
[8] |
| |
|
48. |
|
Pages IH, Jahr S, Schaufele MK, Conradi E:
Comparitive analysis of biofeedback and physical
therapy for treatment of urinary stress
incontinence in women.
Am J Phys Med Rehabil 2001, 80(7):494-502. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] |
| |
|
49. |
|
Pieber D, Zivkovic F, Tamussino K, Ralph G,
Lippitt G, Fauland B: Pelvic foor exercises
alone or with vaginal cones for the treatment of
mild to moderated
stress urinary incontinence in premenopausal women.
Int Urogynecol J Pelvic Floor Dysfunct
1995, 6:14-17. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7]
[8] |
| |
|
50. |
|
Wong KS, Fung KY, Fung SM, Fung CW, Tang CH:
Biofeedback of pelvic floor muscles in the
management of genuine stress incontinence in chinese women.
Physiotherapy 2001, 87(12):644-648. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] |
| |
|
51. |
|
Parkkinen A, Karjalainen E, Vartiainen M,
Penttinen J: Physiotherapy for female stress
urinary incontinence: Individual therapy at the
outpatient clinic versus home-based pelvic floor
training: A 5 year followup study.
Neurourol Urodyn 2004, 23:643-648.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7] |
| |
|
52. |
|
Turkan A, Inci Y, Fazli D: The short term
effects of physical therapy in different
intensities of urodynamic
stress incontinence.
Gynecol Obstet Invest 2005., 59(43-48): |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5] |
| |
|
53. |
|
Balmforth J, Bidmead J, Cardozo L, Hextall A,
Kelvin B, Mantle J: Raising the tone: a
prospective observational study evaluating the
effect of pelvic floor muscle training on
bladder neck mobility and associated improvement
in stress urinary incontinence.
Neurourol Urodyn 2004, 23(5/6):553-54. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5] |
| |
|
54. |
|
Chen H, Chang W, Lin W, L. Y, Hsu T, Tsai H,
Yang K: Efficacy of pelvic floor
rehabilitation for treatment of genuine
stress
incontinence.
Journal of the Formosan Medical Association
1999, 98:271-276. |
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] |
| |
|
55. |
|
Finckenhagen HB, Bo K: The effect of pelvic
floor exercise on stress
urinary incontinence.
Tidsskr Nor Laegeforen 1998, 118(13):2015-2017.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] |
| |
|
56. |
|
Dumoulin C, Seaborne DE, Quirion-DeGirardi C,
Sullivan SJ: Pelvic floor rehabilitation,
Part 2: Pelvic-Floor reeducation with
interferential currents and exercise in the
treatment of genuine stress incontinence in
postpartum women - A Cohort study.
Physical Therapy 1995, 75(12):1075-1081.
|
|
|
|
Return to citation in text: [1]
[2] [3]
[4] [5]
[6] [7] |
| |
|
57. |
|
Neumann P, Gill V: Pelvic floor and abdominal
muscle interaction: EMG activity and
intra-abdominal pressure.
Int Urogynecol J Pelvic Floor Dysfunct
2002, 13:125-132. |
|
|
|
Return to citation in text: [1] |
| |
|
58. |
|
Sapsford R, Hodges PW, Richardson CA, Cooper DH,
Markwell SJ, Jull GA: Co-activation of the
abdominal and pelvic floor muscles during
voluntary exercises.
Neurourol Urodyn 2001, 20:31-42. |
|
|
|
Return to citation in text: [1] |
| |
|
59. |
|
Thompson JA, O'Sullivan PB, Briffa NK, Neumann
PB: Differences in muscle activation patterns
during pelvic floor muscle contraction and
Valsalva manouevre.
Neurourol Urodyn 2006, 25:148-155. |
|
|
|
Return to citation in text: [1] |
| |
|
60. |
|
Sapsford R: Rehabilitation of pelvic floor
muscles utiliszing trunk stabilizaition.
Manual Therapy 2004, 9:3-12. |
|
|
|
Return to citation in text: [1] |
Additional file 3: Levels of
evidence for assessing intervention studies (NHMRC
1999)
[1]
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I |
Evidence obtained from a systematic review of
all relevant randomised controlled trials |
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II |
Evidence obtained from at least one
properly-designed randomised controlled trial |
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III-1 |
Evidence obtained from well-designed
pseudorandomised controlled trials (alternate
allocation or some other method) |
|
III-2
|
Evidence obtained from comparative studies
(including systematic reviews of such studies)
with concurrent controls and allocation not
randomised, cohort studies, case-control
studies, or interrupted time series with a
control group |
|
III-3 |
Evidence obtained from comparative studies with
historical control, two or more single arm
studies, or interrupted time series without a
parallel control group |
|
IV |
Evidence obtained from case series, either
post-test or pre-test/post-test |
Additional
file 4: Summary of critical appraisal � Randomised
controlled trials
[1]
[2]
[3]
[4]
|
Citation |
A
k
s
a
c
2
0
0
3 |
A
r
v
o
n
e
n
2
0
0
1 |
B
e
r
g
h
m
a
n
s
1
9
9
6 |
B
i
d
m
e
a
d
2
0
0
4 |
B
o
1
9
9
9 |
Cammu & van Nylen 1998 |
D
u
m
o
u
l
i
n
2
0
0
4 |
B
o
2
0
0
0 |
G
l
a
v
i
n
d
1
9
9
6 |
H
a
y
|
S
m
i
t
h
2
0
0
2 |
J
o
h
n
s
o
n
2
0
0
1 |
K
n
i
g
h
t
1
9
9
8 |
M
i
l
l
e
r
1
9
9
8 |
M
o
r
k
v
e
d
2
0
0
2 |
P
a
g
e
s
2
0
0
1 |
P
i
e
b
e
r
1
9
9
5 |
W
o
n
g
2
0
0
1 |
T
o
t
a
l |
|
Study purpose
clearly stated |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
16 |
|
Ethical
processes |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
13 |
|
Lit. review
relevant |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
16 |
|
Random
allocation |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
16 |
|
Allocation
concealed |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
9 |
|
Assessors
blinded |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
5 |
|
Baseline
similarity |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
15 |
|
Pre-stratification |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
5 |
|
Consideration of sample size |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
6 |
|
Inclusion/
exclusion criteria |
0 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
14 |
|
OM clearly
described in Intro/Methods |
0 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
12 |
|
OM reliable
stated |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
8 |
|
OM valid
stated |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
8 |
|
Intervention
described to allow replication |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
10 |
|
Contamination avoided |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
5 |
|
Co-intervention avoided |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
4 |
|
Results reported
in terms of significance |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
15 |
|
Analysis
appropriate |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
15 |
|
Withdrawals/
dropouts reported
|
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
15 |
|
Intention to
treat or no dropouts reported |
0 |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
9 |
|
Conclusions appropriate |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
16 |
|
Clinical importance reported |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
14 |
|
Limitations
reported |
0 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
1 |
1 |
1 |
12 |
|
Total |
9 |
15 |
20 |
10 |
23 |
15 |
21 |
21 |
13 |
15 |
15 |
17 |
17 |
22 |
13 |
13 |
16 |
|
KEY: OM = Outcome Measure
Additional file 5: Summary
of critical appraisal � Non-randomised controlled
trials
[1]
[2]
[3] [4]
|
Citation |
Chen
1999 |
Dumoulin 1995 |
Balmforth 2004 |
Turkan 2005 |
Parkkinen 2004 |
Sung
2000 |
Finkenhagen 1998 |
Total |
|
Study purpose clearly stated |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
|
Ethical processes |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
6 |
|
Literature review relevant |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
5 |
|
Assessor blinded |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
2 |
|
Compliance reported |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
No
biases present |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Consideration of sample size |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Inclusion/exclusion criteria |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
3 |
|
OM
clearly described in Intro/methods |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
4 |
|
OM
reliability stated |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
OM
validity stated |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Intervention described (to allow replication) |
0 |
1 |
0 |
1 |
1 |
0 |
1 |
4 |
|
Results reported in terms of significance |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
6 |
|
Analysis appropriate |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
6 |
|
Withdrawals/ dropouts reported |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
4 |
|
Intention to treat, or no dropouts |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
|
Conclusions appropriate |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
6 |
|
Clinical importance reported |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
6 |
|
Limitations reported |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
2 |
|
Total |
11 |
13 |
6 |
11 |
13 |
8 |
5 |
|
OM = Outcome Measure
|
Table 1
[1] |
Summary of all
studies with interventions, level of evidence,
quality rating score and age
|
|
Studies |
Intervention |
Hierarchy of Evidence a |
Quality Rating Score (%) |
Mean age (SD)b |
|
|
Bo (1999) |
PFMT v BF v ES v control |
II |
23/23 (100) |
49.6 (10) |
|
Morkved (2002) |
PFMT v PFMT+BF |
II |
22/23 (96) |
47.8 (8.2) |
Dumoulin (2004)
|
PFMT+ES+BF v PFMT+ES+BF+Ab Ex v control |
II |
21/23 (91) |
36.2 (median) (IQ range 23�39) |
|
Bo (2000) |
PFMT |
II |
21/23 (91) |
49.6 (10) |
|
Berghmans (1996) |
PFMT v PFMT+BF |
II |
20/23 (87) |
48 (range 18�70) |
Knight (1998)
|
PFMT+BF v PFMT+BF+ES('home') v
PFMT+BF+ES('clinic') |
II
|
17/23 (74)
|
NR (range 24�68)
|
|
Miller (1998b) |
PFMT (motor learning) |
II |
17/23 (74) |
68.4 (range 60�84) |
|
Parkkinen (2004) |
PFMT+ES+BF+VW v PFMT+VW |
III-2 |
14/19 (74) |
46.8 (range 32�65) |
|
Wong (2001) |
PFMT+BF v PFMT+BF+Ab BF |
II |
16/23 (70) |
46 (range 30�62) |
|
Dumoulin (1995) |
PFMT+ES+BF |
IV |
13/19 (68) |
32 (9.5) |
|
Johnson (2001) |
PFMT (SVC) v PFMT (NMVC) |
II |
15/23 (65) |
50 (35�65) |
Hay-Smith (2002) A
|
PFMT (motor learning/strength) v PFMT (motor
learning) |
II
|
15/23 (65)
|
48.8 (13.2 SD) |
|
Arvonen (2001) |
PFMT v PFMT+VW |
II |
15/23 (65) |
48 (range 28�65) |
|
Cammu & van Nylen (1998) |
PFMT+BF v VW
|
II
|
15/23 (65)
|
55.9 (9.5)
|
|
Turkan (2005) |
PFMT+ES |
III-2 |
11/19 (58) |
47.6 (8) |
|
Pieber (1995) |
PFMT+BF v PFMT+BF+VW |
II |
13/23 (57) |
43 (+/- 6) |
|
Chen (1999) |
PFMT+ES |
IV |
11/19 (58) |
NS (range 20 to >50) |
|
Glavind (1996) |
PFMT v PFMT+BF |
II |
13/23 (57) |
45 (median)(range 40�48) |
Pages (2001)
|
PFMT v BF
|
II
|
13/23 (57)
|
51.1 (range 27�80)
|
Bidmead (2002) A
|
PFMT v PFMT+ES v PFMT+sham ES v control |
II
|
10/23 (43)
|
NR
|
|
Sung (2000) |
PFMT |
III-2 |
8/19 (42) |
range 18 � >60 |
|
Aksac (2003) |
PFMT v PFMT+BF v control |
II |
9/23 (39) |
52.9 (7.2) |
|
Balmforth (2004) A |
PFMT+BF |
IV |
6/19 (32) |
49.5 (10.6) |
|
Finkenhagen (1998) A |
PFMT
|
IV
|
5/19 (26)
|
49 (range 25�67)
|
|
A = available in
English only as abstract; a =
According to Australian National Health and
Medical Research Council Hierarchy of Evidence
(1998); b = Mean age (SD) unless
otherwise stated; PFMT = pelvic floor muscle
training; ES = electrical stimulation; BF =
biofeedback; VW = vaginal weights; PT =
physiotherapist; UDS = urodynamics studies; NR =
not reported, SVC = submaximal voluntary
contraction, NMVC = near-maximal voluntary
contraction
|
|
Table 2
[1] |
Summary of
studies with factors pertaining to external
validity
|
Studies
|
Diagnosis
|
Intervention by |
Setting
|
Excluded if prior surgery |
Volunteers (V) or Referred (R) |
|
|
Bo (1999) |
S, Pad T, UDS |
PT |
Multicentre |
yes |
V+R |
|
Morkved (2002) |
S, Pad T, UDS |
PT |
NR |
yes |
V |
|
Dumoulin (2004) |
S, Pad T, UDS |
PT |
NR |
yes |
V |
|
Bo (2000) |
S, Pad T, UDS |
PT |
NR |
yes |
NR |
Berghmans (1996)
|
S, CST, Pad T, UDS |
PT
|
PT clinic
|
yes
|
R
|
|
Knight (1998) |
UDS |
PT |
Tertiary Clinic |
no |
NR |
|
Miller (1998) |
S, CST |
NR |
NR |
yes |
NR |
|
Parkkinen (2004) |
S, Pad T, UDS |
PT |
Hospital PT clinic |
no |
NR |
|
Wong (2001) |
S, UDS |
PT |
Hospital PT clinic |
yes |
R |
|
Dumoulin (1995) |
S, Pad T, UDS |
PT |
NR |
NR |
V |
|
Johnson (2001) |
S, UDS |
NR |
NR |
yes |
V+R |
|
Hay-Smith (2002) |
S, CST, Pad T |
PT |
NR |
yes |
V+R |
|
Arvonen (2001) |
S |
PT |
OP PT clinic |
no |
R |
|
Cammu & van Nylen (1998) |
S, UDS
|
PT
|
NR
|
no
|
NR
|
|
Turkan (2005) |
S, Pad T, UDS |
PT |
University PT clinic |
yes |
R |
|
Pieber (1995) |
UDS |
PT |
Urodynamic unit |
yes |
R |
Chen (1999)
|
S, CST, Pad T, UDS |
NR
|
NR
|
yes
|
R
|
|
Glavind (1996) |
S, Pad T, UDS |
NR |
NR |
yes |
NR |
|
Pages (2001) |
S, UDS |
PT |
OP hospital clinic |
no |
R |
|
Bidmead (2002) |
UDS |
PT |
NR |
NR |
NR |
|
Sung (2000) |
S |
PT |
NR |
NR |
R |
|
Aksac (2003) |
UDS |
Therapist |
NR |
NR |
NR |
|
Balmforth (2004) |
S, UDS |
PT |
NR |
yes |
R |
Finkenhagen (1998)
|
NR
|
PT
|
PT clinic (primary care) |
NR
|
NR
|
|
S = symptoms, Pad
T = pad test, CST = cough stress test, UDS =
urodynamic studies, NR = not reported, PT =
physiotherapist, OP = outpatient
|
|
Table 3
[1] |
Baseline severity
of symptoms: incontinent episodes (IE)
and urine loss (g) (pad test)
|
|
Study |
Incontinence Episodes/day |
IE/week |
Urine loss (g) (pad test) |
|
|
Aksac (2003) |
|
|
20 (1 hour) |
|
Arvonen (2001) |
|
|
25 (SPT, st.b.vl) |
|
Balmforth (2004) |
|
|
12.2 (SPT, st.b.vl) |
|
Berghmans (1996) |
2�3 |
|
28 (48 hr pad test) |
|
Bidmead (2002) |
|
|
10 (SPT) |
|
Bo (1999) |
2.0 per 3 days |
|
38.6 (SPT, st.b.vl.); 14.5 (24 hr pad test) |
|
Bo (2000) |
|
|
45 (SPT, st.b.vl) |
|
Cammu & van Nylen (1998) |
|
14.4 |
NR |
|
Chen (1999) |
5.5 |
|
20 (1 hour) |
|
Dumoulin (1995) |
|
|
74.4 (SD 84.3) (SPT, st.b.vl) |
|
Dumoulin (2004) |
|
|
PF group: 12.5 g: PF+ abs group: 20 g (SPT,
st.b.vl) |
|
Finkenhagen (1998) |
|
|
NR |
|
Glavind (1996) |
|
|
10.9 (SPT, st.b.vl) |
|
Hay-Smith (2002) |
1.8 | | | | |
