Pelvic Floor Muscle Training and Therapies for the Treatment of Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a prevalent and costly condition which may be treated surgically or by physical therapy.
Stress urinary incontinence (SUI) is a prevalent and costly condition which may be treated surgically or by physical therapy.
An
Published 28 June 2006
Highly Accessed Research article
Abstract 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 SUI.
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 SUI 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 SUI 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 SUI 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.
BackgroundAim
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 UI 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 UI, 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). SUI is the most common type of UI. 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 SUI and medication with behavioural methods for UUI. The efficacy of surgery is variable [5-7]. Pharmacotherapy for SUI has also been developed but not extensively prescribed [8]. Since 1992, conservative management of UI has been promoted by the US Department of Health and Human Services (AHCPER) as first-line treatment for SUI for its efficacy, low cost and low risk [9].
SUI occurs when intra-vesical pressure exceeds urethral closure pressure in the absence of a detrusor contraction. SUI 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 SUI 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 SUI [13] and UI [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, PFM 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 SUI 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 SUI in women.
The review addressed the following research questions:
1. What is the evidence for PFMT, either alone or in combination with adjunctive therapies, when considering all treatment protocols, for the treatment for SUI 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?
MethodsCriteria 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 PFMT 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 SUI. 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 UI 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 SUI were reported.
Types of interventionsInclusions
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)
Perception of cure and improvement
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
Objective assessment of pelvic floor muscle strength
D. Quality of life
General health status measures (physical, psychological, other)
Condition-specific health measures (specific instruments designed to assess incontinence)
E. Socioeconomic measures
Health economic 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:
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.
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