Physiotherapy OR Tvt Randomised Efficacy Trial
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Stress 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) 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 became 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.
To compare the clinical and cost-effectiveness of pelvic floor muscle training versus TVT/TVT-O surgery as primary treatment of moderate to severe female urinary incontinence.
Multi-centre randomised controlled trial
Women with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Between 35 – 80 years old.
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.
Main study parameters/endpoints:
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 (UDI and IIQ) 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 QALY gained. As the vast majority of relevant outcomes will have occurred by one year this period appears sufficient. Uncertainty will be evaluated using bootstrap techniques (1000 replicates) on the individual patient data. A CEA plane will be used to depict the dispersion of the estimates of incremental costs and effects of TVT(O) compared to PFMT, thus allowing a direct inference with regard to the certainty of one treatment having a better cost effectiveness. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients.
In order to observe a significant difference in subjective improvement, 65% in PFMT and 80% in TVT, with a power of 0.9, a total of 200 women have to be assigned by randomisation to each group.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women in both treatment arms will receive a non-experimental treatment. Both treatment options are recognized as part of standard care. The burden associated with participation is limited to a total of 3 visits to the hospital for data assessment at regular follow-up. There are no specific risks involved in participating
Start inclusion: march 2008, Inclusion period 18 months, follow up period 18 months.
C.H. van der Vaart, MD, PhD, Dept. of Gynaecology, UMC Utrecht
J. Labrie, MD, researcher Dept. of Gynaecology, UMC Utrecht
J.P.W.R. Roovers, MD, PhD - Academisch Medisch Centrum
D.A. Gietelink, MD, PhD - Amphia Ziekenhuis
J. Stoutjesdijk, MD - Canisius Wilhemina Ziekenhuis
P.C. Scholten, MD, PhD - Diakonessenhuis Utrecht
I. van der Wijk, MD - Groene Hart Ziekenhuis
J.M. Van der ploeg, MD - Martini Ziekenhuis
B.W.J. Mol, MD, PhD - Maxima Medisch Centrum
Schraffordt Koops, MD, PhD - Meander Medisch Centrum
A.G. Groenendijk, MD - Onze Lieve Vrouwe Gasthuis
A.L. Milani, MD, PhD - Reinier de Graaf Groep
G.C.M. Graziosi, MD, PhD - Sint Antonius Ziekenhuis
A. Vollebregt, MD - Spaarne Ziekenhuis
C.H. van der Vaart, MD, PhD - Universitair Medisch Centrum Utrecht
C.H. van der Vaart, MD, PhD - ZBC Alant Vrouw b.v.
E.E. Blokhuis, MD - Zuwe Hofpoort Ziekenhuis
J. Labrie, MD, researcher, Dept. of Gynaecology UMC Utrecht
+31 (0)30-693 40 80 (Alant Vrouw Medical Centre )