Background
Stress urinary incontinence (SUI) is a prevalent and
costly condition which may be treated surgically or
by physical therapy. The aim of this review was to
systematically assess the literature and present the
best available evidence for the efficacy and
effectiveness of pelvic floor muscle training (PFMT)
performed alone and together with adjunctive
therapies (eg biofeedback, electrical stimulation,
vaginal cones) for the treatment of female Stress Urinary Incontinence.
Methods
All major electronic sources of relevant information
were systematically searched to identify
peer-reviewed English language abstracts or papers
published between 1995 and 2005. Randomised
controlled trials (RCTs) and other study designs eg
non-randomised trials, cohort studies, case series,
were considered for this review in order to source
all the available evidence relevant to clinical
practice.
Studies of adult women with a urodynamic or clinical
diagnosis of Stress Urinary Incontinence were eligible for inclusion.
Excluded were studies of women who were pregnant,
immediately post-partum or with a diagnosis of mixed
or urge incontinence. Studies with a PFMT protocol
alone and in combination with adjunctive physical
therapies were considered.
Two independent reviewers assessed the eligibility
of each study, its level of evidence and the
methodological quality. Due to the heterogeneity of
study designs, the results are presented in
narrative format.
Results
Twenty four studies, including 17 RCTs and seven
non-RCTs, met the inclusion criteria. The
methodological quality of the studies varied but
lower quality scores did not necessarily indicate
studies from lower levels of evidence. This review
found consistent evidence from a number of high
quality RCTs that PFMT alone and in combination with
adjunctive therapies is effective treatment for
women with Stress Urinary Incontinence with rates of 'cure' and
'cure/improvement' up to 73% and 97% respectively.
The contribution of adjunctive therapies is unclear
and there is limited evidence about treatment
outcomes in primary care settings.
Conclusion
There is strong evidence for the efficacy of
physical therapy for the treatment for Stress Urinary Incontinence in women
but further high quality studies are needed to
evaluate the optimal treatment programs and training
protocols in subgroups of women and their
effectiveness in clinical practice.
Background
Aim
The aim of this review was to critically appraise
relevant peer-reviewed reports of original
investigations of the efficacy or effectiveness of
pelvic floor muscle training (PFMT) performed alone
and together with other adjunctive physical
therapies (eg biofeedback, electrical stimulation,
vaginal cones) for stress urinary incontinence in
women published in the last decade (1995�2005).
Background and
rationale
The International Continence Society defines
urinary
incontinence (UI) as the complaint of any
involuntary leakage of urine [1].
It is a widespread [2] and
prevalent condition affecting an estimated 1.8
million community-dwelling women over the age of 18
years in Australia [3]. The
personal financial costs for women managing Urinary Incontinence in
Australia in 1998 were estimated at A$372 million
per annum and the total annual costs of treatment at
A$339 million [4].
Stress and urge incontinence are the two most common
types of Urinary Incontinence, which co-exist as mixed incontinence.
Urine leakage is classified according to what is
reported by the woman (symptoms), what is observed
by a clinician (signs) and on the basis of urodynamic studies.
Stress urinary incontinence (SUI)
is the complaint of involuntary leakage on effort or
exertion, sneezing or coughing (symptom) or the
observation of urine leakage at the same time as the
exertion (sign). Stress Urinary Incontinence is the most common type of Urinary Incontinence.
Urge urinary incontinence (UUI) is the complaint of
involuntary leakage accompanied or immediately
preceded by, urgency [1]. Both are
amenable to conservative therapy but surgery has
conventionally been offered for Stress Urinary Incontinence and medication
with behavioural methods for Urge Urinary Incontinence. The efficacy of
surgery is variable [5-7].
Pharmacotherapy for Stress Urinary Incontinence has also been developed but
not extensively prescribed [8].
Since 1992, conservative management of Urinary Incontinence has been
promoted by the US Department of Health and Human
Services (AHCPER) as first-line treatment for Stress Urinary Incontinence
for its efficacy, low cost and low risk [9].
Stress Urinary Incontinence
occurs when intra-vesical pressure exceeds
urethral closure pressure in the absence of a
detrusor contraction. Stress Urinary Incontinence may be due to bladder neck
hyper-mobility or poor urethral closure pressure [1].
The pelvic floor muscles (PFM) function to elevate
the bladder, preventing descent of the bladder neck
during rises in intra-abdominal pressure and to
occlude the urethra. The theoretical basis for
physical therapy to treat Stress Urinary Incontinence is to improve PFM
function by increasing strength, coordination, speed
and endurance [10] in order to
maintain an elevated position of bladder neck during
raised intra-abdominal pressure with adequate
urethral closure force [11].
A distinction is to be made between the terms
'efficacy' and 'effectiveness'. Efficacy is defined
as "the probability of benefit to individuals in a
defined population from a medical technology applied
for a given medical problem under ideal conditions
of use". By contrast, effectiveness is considered to
have all the attributes of efficacy but to reflect
"performance under ordinary conditions by the
average practitioner for the typical patient" [12].
Pelvic floor muscle training (PFMT) and other
physical therapies for the treatment of female Stress Urinary Incontinence [13]
and Urinary Incontinence [14-16] has been the
subject of previous systematic reviews. All of these
reviews limited their inclusion criteria to
randomized controlled trials, because this type of
study design is considered to provide the best
evidence of efficacy for an intervention by
attempting to minimize biases and confounding
variables [17].
Because of the very rigor of an RCT, it may not
necessarily be appropriate to generalise the results
of such a carefully controlled trial into clinical
practice. Thus a treatment modality with
demonstrated efficacy in an RCT may not be effective
when combined with other modalities for a different
patient population in clinical practice [12,18,19].
Subjects for RCTs are selected according to strict
and often limited criteria, health personnel are
highly trained and a standardized intervention is
applied to all subjects, regardless of individual
subject characteristics and clinical presentations (eg
severity of incontinence, Pelvic Floor Muscle function (strength,
endurance, awareness)[20,21].
In clinical practice, physiotherapists are trained
to provide treatment based on individual assessment
and clinically reasoned processes, for patients
presenting with incontinence and with a range of
co-morbidities. Thus different treatment modalities
(adjunctive therapies) may be applied to individual
patients in conjunction with PFMT in order to
activate a weak muscle, to improve sensory feedback,
to enhance patient cooperation and compliance with
an exercise program [22].
Observational studies provide the opportunity to
establish the effectiveness of such interventions in
routine clinical practice [19].
This is difficult to achieve in randomized trials [19]
other than pragmatic randomized trials [23].
The effectiveness of physical therapy in clinical
practice may thus be assessed from the evidence from
lower level studies i.e. levels III & IV according
to the Australian National Health and Medical
Research Council's hierarchy of evidence [24].
These studies would be more likely to report on
cohorts or case series of patients, treated under
typical clinical conditions. In addition, such
studies could also provide other information about
clinical practice, such as the responsiveness to
treatment (length of time taken to respond) not
otherwise available from an RCT. No systematic
review on Stress Urinary Incontinence has reported on the generalisability
(external validity) of the study findings and their
applicability in clinical practice. External
validity is an important aspect of methodological
quality, but there are few critical review tools to
evaluate whether the procedures, hospital
characteristics and patient samples reported in the
literature are relevant to clinical practice [25].
Objective
This systematic literature review evaluated the
evidence for the efficacy and effectiveness of
physical therapy, described as pelvic floor muscle
training with, and without, adjunctive physical
therapies such as biofeedback, electrical
stimulation or vaginal weights for the treatment of
Stress Urinary Incontinence in women.
The review addressed the following research
questions:
1. What is the evidence for Pelvic Floor Muscle Training, either alone or in
combination with adjunctive therapies, when
considering all treatment protocols, for the
treatment for Stress Urinary Incontinence in women, in the short and medium
terms (up to 12 months after treatment)?
2. What is the evidence for different types of PFMT?
3. What other reported factors could affect outcome
of physical therapy?
4. What is the optimal period of treatment and
number of treatments?
5. What is the effectiveness of physical therapy in
clinical practice settings and can the findings in
the research settings be generalised to clinical
practice?
Methods
Criteria for
inclusion in this review
The methods for conducting this systematic review
and for assessing the quality of the evidence are
based on the processes outlined by the Joanna Briggs
Institute [26] and the Centre for
Reviews and Dissemination at the University of York
[21].
Types of studies
In order to better understand whether those
interventions which have demonstrated efficacy in
the research setting are also effective when applied
in the clinical setting, prospective research
designs other than RCTs were also considered in this
review. These included quasi-experimental,
controlled clinical trials, observational studies
and case studies/series. It was anticipated that
these types of research designs may provide
information about patient populations more typical
of those encountered in primary care settings eg
with a broad range of inclusion criteria. This
information is needed to underpin estimates of the
costs of treatment in the primary care setting.
In this review, experimental studies were classified
as RCTs when randomly allocated intervention groups
were compared, where a distinct control group could
receive either another treatment modality or 'no
treatment'. Thus studies were eligible for inclusion
if there was at least one arm with a Pelvis Floor Muscle Training protocol,
alone or together with other adjunctive therapies,
compared with either a control group of 'no
treatment' or 'usual treatment' or a different PFMT
protocol, alone or together with other adjunctive
therapies (biofeedback, electrical stimulation or
vaginal weights).
Study designs without a control group but with a
PFMT protocol, alone or together with other
adjunctive therapies were also included. Studies or
arms of studies which did not have a PFMT protocol
and retrospective analyses or audits, which were
unlikely to provide robust evidence of effectiveness
because of time-based bias, were excluded.
Only peer-reviewed studies published in English in
the last decade (1995�2005) were included in this
review. The search was limited to the last decade in
order to source the most recent, high-quality
evidence [27]. This decision was
justified on the grounds that systematic reviews
evaluating the earlier literature found many of the
included studies to be of poor or moderate
methodological quality [13-15]
and based on the findings of Moseley et al (2002),
it was assumed that the more recent literature was
more likely to be of higher methodolgical quality.
Types of
participants
The study populations considered in this review
included subjects who were adult females of any age,
not pregnant or within six weeks post-partum, with a
clinical or urodynamic diagnosis of Stress Urinary Incontinence. Clinical
diagnosis could be based on the self-report
(symptom) and/or sign of stress incontinence.
Studies were excluded if they included subjects with
mixed Urinary Incontinence or detrusor overactivity because of the
assumption of a different underlying pathology and
thus rationale of treatment, even if outcomes for
subgroups of women with Stress Urinary Incontience were reported.
Types of
Interventions
Inclusions
Any PFMT i.e. pelvic floor muscle exercises, with
application of a specific training protocol or PFMT
together with any combination of adjunctive
therapies: biofeedback (BF), electrical stimulation
(ES), vaginal weights or cones (VW). All types of BF
were included if it was used to enhance the
awareness of a correct PFM contraction: EMG
(electromyography, either vaginal or surface
abdominal), vaginal squeeze pressure or ultrasound.
Biofeedback could be used to enhance teaching of the
correct response or to train repetitive PFM
contractions.
ES included any low or medium frequency current
applied externally (interferential currents) or
internally via a vaginal electrode.
Exclusions
Interventions that included any of the therapies
listed above as adjunctive, either alone or in
combination, without a PFMT protocol. Thus in
studies which included a subgroup which was treated
with one or more adjunctive therapies without a
specific PFMT protocol, the results of the subgroup
were excluded from the analysis. Thus BF, ES and VW
were not considered on their own or together unless
they were part of program with a PFMT protocol.
Adjunctive therapies have been the subject of
previous reports [15,28].
Types of Outcome
Measures
Only outcome measures relevant for clinical practice
were reported in this review, thus urodynamic study
measures were excluded.
The principal measures of effectiveness were
considered to be the proportion of women cured
(continent/dry), and the proportion of women whose
symptoms were improved based on clinical measures
such as pad tests, urinary diaries or quality of
life scores.
In line with the recommendations of the
International Continence Society, outcomes were
considered the under the following five categories [29]:
A. Women's
observations (subjective measures)
B. Quantification
of symptoms (objective measures)
-
Pad changes over 24 hours (self-reported)
-
Incontinent episodes
over 24 hours (self-completed bladder chart)
-
Pad tests of quantified
leakage (mean volume or weight of urine loss)
C. Clinician's
observations
D. Quality of
life
-
General health status
measures (physical, psychological, other)
-
Condition-specific
health measures (specific instruments designed to
assess incontinence)
E. Socioeconomic
measures
This review also included other information about
progression to surgical intervention and adverse
events. All outcome measures were documented and
categorized under the headings described above.
Search
Strategy
To identify all relevant studies for the review, the
search strategy comprised searches of the following:
Bibliographic Databases:MEDLINE, CINAHL, AMED,
Current Contents, The Cochrane Library, Cochrane
Database of Systematic Reviews (CDSR), The Cochrane
Controlled Trials Registers (CCTR), SPORTdiscus,
CatchWord, AUSTHealth, Academic search elite,
Science Direct, PubMed, Ageline, PEDro, OVID
Internet source:
http://www.yahoo.com,
http://www.google.com
Reference lists of systematic reviews,
meta-analyses, reviews and the studies identified by
the search strategy above were pearled for
additional relevant source material. Their inclusion
was validated by checking their key words against
the search terms. Hand searching for published and
unpublished data was not performed because a
systematic and thus reproducible approach could not
be guaranteed.
All relevant studies with an English language
abstract were located for assessment against the
inclusion criteria. Date of the last search was 20
May 2005. Individual strategies were developed for
each source searched to accommodate search engine
idiosyncrasies. The core terms and search strategies
used for each literature source are listed in
additional file 1.
Eligibility
criteria
Study selection
Relevant articles were identified from the hits
produced from each library database, internet source
or reference lists by applying the eligibility
criteria. The relevant eligible studies were
documented in a Microsoft Excel (2000) database [see
additional file 2].
The full text version of all relevant peer-reviewed
studies was obtained where possible, and abstracts
were only included as a proxy for the complete text
if sufficient data was available in the abstract to
assess and fulfill all the eligibility criteria, to
critically appraise and to provide point measures on
at least one measure of outcome. Inclusion of
studies into this review was reached by consensus
between the two reviewers.
