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Vaginal prolapse repair with or without a midurethral sling in women with genital prolapse and occult stress urinary incontinence: a randomized trial

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Abstract

Introduction and hypothesis

We compared pelvic organ prolapse (POP) repair with and without midurethral sling (MUS) in women with occult stress urinary incontinence (SUI).

Methods

This was a randomized trial conducted by a consortium of 13 teaching hospitals assessing a parallel cohort of continent women with symptomatic stage II or greater POP. Women with occult SUI were randomly assigned to vaginal prolapse repair with or without MUS. Women without occult SUI received POP surgery. Main outcomes were the absence of SUI at the 12-month follow-up based on the Urogenital Distress Inventory and the need for additional treatment for SUI.

Results

We evaluated 231 women, of whom 91 randomized as follows: 43 to POP surgery with and 47 without MUS. A greater number of women in the MUS group reported absence of SUI [86 % vs. 48 %; relative risk (RR) 1.79; 95 % confidence interval (CI) 1.29–2.48]. No women in the MUS group received additional treatment for postoperative SUI; six (13 %) in the control group had a secondary MUS. Women with occult SUI reported more urinary symptoms after POP surgery and more often underwent treatment for postoperative SUI than women without occult SUI.

Conclusions

Women with occult SUI had a higher risk of reporting SUI after POP surgery compared with women without occult SUI. Adding a MUS to POP surgery reduced the risk of postoperative SUI and the need for its treatment in women with occult SUI. Of women with occult SUI undergoing POP-only surgery, 13 % needed additional MUS. We found no differences in global impression of improvement and quality of life.

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Acknowledgments

We thank the Dutch Urogynecology Consortium for data collection: Marlies Y. Bongers, Karin S. Dekker, Hugo W.F. van Eijndhoven, Iris van Gestel, Kirsten B. Kluivers, Gerold Link, Aaltje J. Schram (deceased), Jelle Stekelenburg, Annemarie E. Weis-Potters and Jac Wijma.

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Corresponding author

Correspondence to J. Marinus van der Ploeg.

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Funding

An unrestricted grant was received by the Dutch Ohra Fund.

Conflicts of interest

Jan-Paul W.R. Roovers: medical consultant for American Medical Systems (AMS). C. Huub van der Vaart: medical consultant for consultancy for BARD Medical.

Ethical approval

The study was conducted in accordance with ethical principles derived from the Declaration of Helsinki, Good Clinical Practice, and International Conference of Harmonization Guidelines. All patients provided written informed consent. Ethical approval was provided by the institutional review board of the Academic Medical Centre in Amsterdam (MEC 05/286, January 2006), and all boards of the participating hospitals.

Additional information

The complete list of authors and collaborators from the Dutch Urogynaecology Consortium are listed in Supporting Information, Table A1 of the “Appendix”.

Trial registration

The Netherlands Trial Register NTR1070 (www.trialregister.nl).

Study website

www.studies-obsgyn.nl/cupido

Electronic supplementary material

Below is the link to the electronic supplementary material.

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van der Ploeg, J.M., Rengerink, K.O., van der Steen, A. et al. Vaginal prolapse repair with or without a midurethral sling in women with genital prolapse and occult stress urinary incontinence: a randomized trial. Int Urogynecol J 27, 1029–1038 (2016). https://doi.org/10.1007/s00192-015-2924-1

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  • DOI: https://doi.org/10.1007/s00192-015-2924-1

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