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Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials |
Berghmans L C, Hendriks H J, de Bie R A, van Waalwijk E S, van Doorn E S, Bo K, van Kerrebroeck P H |
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Authors' objectives To assess the efficacy of physical therapies for first-line use in the treatment of urge urinary incontinence (UUI) in women.
Searching MEDLINE, EMBASE, the database of the Dutch National Institute of Allied Health Professions, and the database of the Cochrane Rehabilitation and Related Therapies Field at Maastricht University were searched (search dates not stated). The keywords are listed in the paper. Citation tracking and review of the proceedings of ICS meetings from 1980 to 1998 were undertaken. Several databases not on computer were also screened for physiotherapy journals not covered by MEDLINE. Experts in the field were consulted for additional information. Studies published in English, German or Dutch were included in the review. Unpublished studies and abstracts were excluded.
Study selection Study designs of evaluations included in the reviewRandomised trials that compared treatment to no treatment or placebo, or to standard/active intervention.
Specific interventions included in the reviewPhysical therapies included bladder (re)training, pelvic floor muscle exercises, with or without biofeedback and/or electrical stimulation (intra-vaginal or intra-anal).
Participants included in the reviewWomen with urge urinary incontinence (UUI).
Outcomes assessed in the reviewStudies had to report reliable and clinically relevant outcome measures to be included in the review.
How were decisions on the relevance of primary studies made?Two independent reviewers assessed all RCTs for inclusion. Disagreements were resolved by consensus and, when required, a third reviewer made a final decision. Other reviews were consulted to validate the list of studies included.
Assessment of study quality Study quality was assessed using a modified list of predefined criteria. Criteria assessed were: description of inclusion criteria, at least 50 patients per group, pre-stratification, randomisation, presentation of baseline characteristics, withdrawals, blinding, description of intervention, relevance and description of outcome measurements, analysis and presentation of results. Two independent reviewers assessed all RCTs for methodological quality. Disagreements were resolved by consensus and when required a third reviewer made a final decision. A score of one point was given to each criterion fulfilled, and 0 if not fulfilled. Criteria were graded as 0.5 points if the description was unclear, or if criteria were incompletely fulfilled. The maximum score was 10 points.
Data extraction The authors do not state how the data were extracted for the review, or how many of the reviewers performed the data extraction. Data were extracted on sample size, age, duration and severity of complaints and treatment duration.
Methods of synthesis How were the studies combined?Studies were combined in a level of evidence synthesis. Study results were classified as follows:
Strong evidence: at least three high quality studies (quality score of at least 5.5 points) with consistent results in favour of, or opposing, the intervention were needed. Such results were considered consistent when the pooled-effect estimate showed a clinically relevant or a statistically significant result in favour of the intervention, or opposing it, for at least one outcome measure, or when at lest 75% of the included studies were categorised as positive or negative. A study was considered positive or negative when it showed a clinically important or a statistically significant result in favour of, or opposing, the intervention for at least one outcome measure.
Weak evidence in favour of the intervention: at least three high quality studies with inconsistent results or at least three low quality studies with consistent results in favour of the intervention. Results were considered inconsistent across studies when 25-75% of them were considered positive.
Weak evidence against the intervention: at least three low quality studies with consistent results against the intervention. Results were considered consistent when the pooled-effect estimate showed clinically important or statistically significant result against the intervention for at least one outcome measure, or when 25% or less of these studies were considered positive.
Insufficient evidence: when there were low-quality studies with inconsistent results or with fewer than three studies of whatever quality.
How were differences between studies investigated?The authors do not state whether differences between the studies were investigated.
Results of the review Fifteen RCTs (n=838).
Bladder retraining compared to no treatment (n=4): there was strong evidence that bladder retraining is more effective than placebo.
Bladder retraining compared to drug therapy (n=3): there was weak that bladder retraining is more effective than no treatment and drug treatment.
There was insufficient evidence on the effectiveness of the following interventions:
Bladder retraining and drug treatment compared to bladder retraining and placebo (n=1).
Bladder retraining with prior urodynamics compared to bladder retraining with no urodynamics (n=1).
Bladder retraining compared to biofeedback assisted pelvic floor muscle exercises compared to combination therapy (n=1).
Biofeedback assisted bladder retraining compared to placebo drug therapy(n=1).
Behavioural treatment compared to routine incontinence-related care (n=1).
Intra-vaginal or intra-anal electrical stimulation (ES) compared to sham ES (n=3).
Intra-vaginal ES compared with drug therapy (n=1).
Authors' conclusions Although almost all studies included reported positive results in favour of physical therapies for the treatment of UUI, more research of high methodological quality is required to evaluate the effects of each method in the range of physical therapies.
CRD commentary A good review of the area. A thorough literature search was conducted thus it is unlikely that any important publications have been missed, however inclusion criteria did limit studies to those published in English, German or Dutch which may have excluded some important studies from the review. Unpublished studies were excluded and so the results may be subject to publication bias. Inclusion criteria were clearly stated, methodological details are provided and individual study details are provided in tables in the text. Results were synthesised appropriately and were clearly presented. The methodological quality of the included studies was assessed and discussed in the results, the authors highlight the range in quality of the included studies and state that this means that results should be interpreted with caution. The authors conclusions follow from the results presented.
Implications of the review for practice and research Research: The authors state that 'more research of high methodological quality is required to evaluate the effects of each method in the range of physical therapies'. They suggest the following definition for bladder overactivity 'bladder overactivity is a dysfunction of the bladder in which a subject has no or decreased control over sudden contractions of the detrusor muscle, so that this leads to premature leakage of urine', and state that 'to meet the demand for a quantitative assessment of this dysfunction a highly sensitive and specific diagnostic tool with a validated quantitative outcome measure is necessary'.
Bibliographic details Berghmans L C, Hendriks H J, de Bie R A, van Waalwijk E S, van Doorn E S, Bo K, van Kerrebroeck P H. Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials. BJU International 2000; 85(3): 254-263 Other publications of related interest 1. Hendriks HJM, Berghmans LCM, de Bie RA, Bernards ATM, Bo K, Hay-Smith EJ, van Waalwijk van Doorn ESC. Effectiviteit van fysiotherapie bij vrouwen met stress urine-incontinentie: een systematisch overzicht van gerandomiseerde studies. Ned T Fysiother 1998;108(4):103-112.
Indexing Status Subject indexing assigned by NLM MeSH Behavior Therapy /methods; Biofeedback, Psychology; Electric Stimulation Therapy /methods; Exercise Therapy /methods; Female; Humans; Physical Therapy Modalities /methods; Randomized Controlled Trials as Topic; Treatment Outcome; Urinary Incontinence /rehabilitation AccessionNumber 12000000524 Date bibliographic record published 31/05/2001 Date abstract record published 31/05/2001 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
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