van Leijsen Sanne A L, Kluivers Kirsten B, Mol Ben Willem J, Broekhuis Suzan R, Milani Fred L, van der Vaart C Huub, Roovers Jan-Paul W R, Bongers Marlies Y, den Boon Jan, Spaans Wilbert A, de Leeuw Jan Willem, Dietz Viviane, Kleinjan Jan H, Brölmann Hans A M, Roos Eveline J, Schaafstra Judith, Heesakkers John P F A, Vierhout Mark E
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
BMC Womens Health. 2009 Jul 21;9:22. doi: 10.1186/1472-6874-9-22.
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.
Clinical Trials NCT00814749.
压力性尿失禁（SUI）是一个常见问题。在荷兰，每年有64000名新患者因尿失禁咨询全科医生，其中96%为女性。每年大约进行7500次尿动力学评估以及大约5000例SUI手术。在妇科和泌尿科学会的所有主要国家和国际指南中，均建议在对SUI进行侵入性治疗前进行尿动力学检查，但尚未在随机对照研究中评估其有效性和成本效益。压力性尿失禁手术前尿动力学检查的价值（VUSIS）研究评估了对于考虑手术治疗的SUI症状女性，尿动力学检查在结局方面的正反两方面影响以及成本。
方法/设计：将开展一项多中心诊断队列研究，并在表现出（主要为）SUI症状的女性中进行一项嵌入式随机对照试验。必须通过临床检查和/或排尿日记证实存在尿失禁。物理治疗必须已失败且需要考虑手术治疗。如果既往有尿失禁手术史、盆腔器官脱垂超过处女膜1厘米以上和/或超声或导尿显示残余膀胱容量超过150毫升，则将患者排除。尿动力学检查诊断与基于病史、临床检查和/或排尿日记的诊断结果不一致的患者，将根据所有可用信息随机分配接受手术治疗或个体化定制治疗。治疗后，由主治泌尿科医生或妇科医生对患者进行两年随访，并完成问卷调查。将从荷兰约27家医院招募600名女性患者进行登记。我们预计将有102名检查结果不一致的女性被随机分组。本研究的主要结局是用经过验证的荷兰版尿失禁困扰量表（UDI）测量的尿失禁临床改善情况。本研究的次要结局包括成本、通过排尿日记参数测量的尿失禁治愈情况、与干预相关的并发症、再次干预以及一般生活质量变化。
临床试验编号NCT00814749。
