Abstract
BackgroundStress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial.Methods/DesignA multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the NetherlandsTrial registrationNederlands trial register: NTR 1248
Highlights
Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden
Pelvic floor muscle training (PFMT) is currently advised as primary treatment, because it is statistically significant more likely to improve incontinence symptoms as compared to no or sham physiotherapy.[2]
The main objective of our study is to answer the question whether it is more effective to refer for specialised PFMT or for Tension-free Vaginal Tape (TVT)(O) surgery after the standard initial instruction and training given by the general practitioner (GP) has failed
Summary
Urinary incontinence is a common problem among adult women, with an estimated overall prevalence of 40% and between 6-10% of women with severe incontinence.[1]. The main objective of our study is to answer the question whether it is more (cost) effective to refer for specialised PFMT or for TVT(O) surgery after the standard initial instruction and training given by the GP has failed Primary surgery in this group of patients may be costeffective when compared to PFMT as its cure rate is higher. A comparison of both strategies has been performed in a small sample of patients comparing abdominal Burch surgical procedure versus PFMT.[11] this single study concluded that primary surgery was preferable, the design and power did not meet the standards to provide sufficient scientific evidence It is unclear which factors are associated with success or failure of PFMT and TVT. In addition to our cost-effectiveness analyses we aim to develop such a prediction model
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