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

S. A L Van Leijsen, K. B. Kluivers, B. W J Mol, S. R. Broekhuis, A. L. Milani, M. Y. Bongers, C. I M Aalders, V. Dietz, G. G A Malmberg, M. E. Vierhout, J. P F A Heesakkers

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

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: 0.70-42). 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: 0.56-36). 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. 31:1118-1123, 2012. © 2012 Wiley Periodicals, Inc.

LanguageEnglish
Pages1118-1123
Number of pages6
JournalNeurourology and Urodynamics
Volume31
Issue number7
DOIs
Publication statusPublished - 1 Sep 2012

Keywords

  • diagnostic
  • outcome
  • stress incontinence
  • surgery
  • urodynamics

ASJC Scopus subject areas

  • Clinical Neurology
  • Urology

Cite this

Van Leijsen, S. A. L., Kluivers, K. B., Mol, B. W. J., Broekhuis, S. R., Milani, A. L., Bongers, M. Y., ... Heesakkers, J. P. F. A. (2012). Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. Neurourology and Urodynamics, 31(7), 1118-1123. https://doi.org/10.1002/nau.22230
Van Leijsen, S. A L ; Kluivers, K. B. ; Mol, B. W J ; Broekhuis, S. R. ; Milani, A. L. ; Bongers, M. Y. ; Aalders, C. I M ; Dietz, V. ; Malmberg, G. G A ; Vierhout, M. E. ; Heesakkers, J. P F A. / Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. In: Neurourology and Urodynamics. 2012 ; Vol. 31, No. 7. pp. 1118-1123.
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abstract = "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: 0.70-42). 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: 0.56-36). 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. 31:1118-1123, 2012. {\circledC} 2012 Wiley Periodicals, Inc.",
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author = "{Van Leijsen}, {S. A L} and Kluivers, {K. B.} and Mol, {B. W J} and Broekhuis, {S. R.} and Milani, {A. L.} and Bongers, {M. Y.} and Aalders, {C. I M} and V. Dietz and Malmberg, {G. G A} and Vierhout, {M. E.} and Heesakkers, {J. P F A}",
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Van Leijsen, SAL, Kluivers, KB, Mol, BWJ, Broekhuis, SR, Milani, AL, Bongers, MY, Aalders, CIM, Dietz, V, Malmberg, GGA, Vierhout, ME & Heesakkers, JPFA 2012, 'Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial', Neurourology and Urodynamics, vol. 31, no. 7, pp. 1118-1123. https://doi.org/10.1002/nau.22230

Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. / Van Leijsen, S. A L; Kluivers, K. B.; Mol, B. W J; Broekhuis, S. R.; Milani, A. L.; Bongers, M. Y.; Aalders, C. I M; Dietz, V.; Malmberg, G. G A; Vierhout, M. E.; Heesakkers, J. P F A.

In: Neurourology and Urodynamics, Vol. 31, No. 7, 01.09.2012, p. 1118-1123.

Research output: Contribution to journalArticle

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T1 - Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial

AU - Van Leijsen, S. A L

AU - Kluivers, K. B.

AU - Mol, B. W J

AU - Broekhuis, S. R.

AU - Milani, A. L.

AU - Bongers, M. Y.

AU - Aalders, C. I M

AU - Dietz, V.

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N2 - 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: 0.70-42). 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: 0.56-36). 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. 31:1118-1123, 2012. © 2012 Wiley Periodicals, Inc.

AB - 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: 0.70-42). 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: 0.56-36). 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. 31:1118-1123, 2012. © 2012 Wiley Periodicals, Inc.

KW - diagnostic

KW - outcome

KW - stress incontinence

KW - surgery

KW - urodynamics

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