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Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.

van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brölmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME - BMC Womens Health (2009)

Bottom Line: Stress urinary incontinence (SUI) is a common problem.In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence.Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. sannevanleijsen@hotmail.com

ABSTRACT

Background: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered.

Methods/design: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes.

Trial registration: Clinical Trials NCT00814749.

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Summary of trial design.
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Figure 1: Summary of trial design.

Mentions: The VUSIS is a multidisciplinary, multicentre diagnostic cohort study with a randomized controlled trial (RCT) embedded. All women with symptoms of predominantly SUI in whom surgical treatment is considered will undergo urodynamic investigation. Only women with a discordant finding compared to history and physical examination will be randomized. Patients with concordant urodynamics will be registered [see figure 1].


Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.

van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brölmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME - BMC Womens Health (2009)

Summary of trial design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2722584&req=5

Figure 1: Summary of trial design.
Mentions: The VUSIS is a multidisciplinary, multicentre diagnostic cohort study with a randomized controlled trial (RCT) embedded. All women with symptoms of predominantly SUI in whom surgical treatment is considered will undergo urodynamic investigation. Only women with a discordant finding compared to history and physical examination will be randomized. Patients with concordant urodynamics will be registered [see figure 1].

Bottom Line: Stress urinary incontinence (SUI) is a common problem.In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence.Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. sannevanleijsen@hotmail.com

ABSTRACT

Background: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered.

Methods/design: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes.

Trial registration: Clinical Trials NCT00814749.

Show MeSH
Related in: MedlinePlus