Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial

被引:69
作者
van Leijsen, S. A. L. [1 ]
Kluivers, K. B. [1 ]
Mol, B. W. J. [2 ]
Broekhuis, S. R. [1 ]
Milani, A. L. [3 ]
Bongers, M. Y. [4 ]
Aalders, C. I. M. [5 ]
Dietz, V. [6 ]
Malmberg, G. G. A. [7 ]
Vierhout, M. E. [1 ]
Heesakkers, J. P. F. A. [8 ]
机构
[1] Radboud Univ Nijmegen, Med Ctr, Dept Obstet & Gynecol, NL-6500 HB Nijmegen, Netherlands
[2] Univ Amsterdam, Acad Med Ctr, Dept Obstet & Gynecol, NL-1105 AZ Amsterdam, Netherlands
[3] Reinier de Graaf Gasthuis, Dept Obstet Gynecol, Delft, Netherlands
[4] Maxima Med Ctr, Dept Obstet Gynecol, Veldhoven, Netherlands
[5] Rijnstate Hosp, Dept Obstet Gynecol, Arnhem, Netherlands
[6] Catharina Hosp, Dept Obstet Gynecol, Eindhoven, Netherlands
[7] Slingeland Hosp, Dept Obstet & Gynecol, Doetinchem, Netherlands
[8] Radboud Univ Nijmegen, Med Ctr, Dept Urol, NL-6500 HB Nijmegen, Netherlands
关键词
diagnostic; outcome; surgery; stress incontinence; urodynamics; FREE VAGINAL TAPE; QUALITY-OF-LIFE; IMPACT QUESTIONNAIRE; HEALTH; DYSFUNCTION; GUIDELINES; CYSTOMETRY; RISK;
D O I
10.1002/nau.22230
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Aims To assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment. Methods We performed a multicenter non-inferiority randomized controlled trial. Women with SUI were randomly allocated to management based on a workup with or without urodynamics. The primary outcome was clinical reduction of complaints as measured with the Urogenital Distress Inventory urinary incontinence subscale (UDI-UI) at 12 months after the onset of treatment. A mean difference in improvement of less than 8 was considered non-inferior. The study was analyzed according to intention-to-treat. Results The trial was stopped prematurely because of slow recruitment. We randomly allocated 59 women to a strategy with (N?=?31) or without (N?=?28) urodynamics. The mean difference in improvement on the UDI-UI was 14 in favor of the group without urodynamics (48 SD?+/-?22 vs. 34 SD?+/-?22, 95% CI: -28 to -0.26), confirming non-inferiority. Addition of urodynamics did not result in a lower occurrence of de novo overactive bladder complaints compared to a workup without urodynamics (6/31 vs. 1/28; RR 5.4, 95% CI: 0.7042). In the group allocated to urodynamics, initial surgical management was more often abandoned compared to the group not allocated to urodynamics (5/31 vs. 1/28; RR 4.5, 95% CI: 0.5636). Conclusions In this relatively small study, the omission of urodynamics was not inferior to the use of urodynamics in the preoperative workup of women with SUI. Women with SUI undergoing urodynamics had the risk of a choice for more prudent treatment, which seemed to result in a delay until effective treatment. Neurourol. Urodynam. 31:11181123, 2012. (c) 2012 Wiley Periodicals, Inc.
引用
收藏
页码:1118 / 1123
页数:6
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