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Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial

A Correspondence to this article was published on 08 July 2020

A Correspondence to this article was published on 02 June 2020

Abstract

Purpose

Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact® vs. RetroArc®) inserted in two different ways regarding perioperative and mid-term outcomes.

Methods

In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients’ satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure.

Results

Of the 303 women, 152 were randomized to the TVT® and 151 to the RetroArc® operation. At 3 months, n = 288 (95.0%) and at 12 months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc®-procedure was not inferior to TVT® (p = 0.144). In subjective cure, however, the TVT exact® procedure achieved significant better results (TVT® 76.1%, RetroArc® 54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact®-procedure.

Conclusions

Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.

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Acknowledgements

The authors acknowledge the initial support by a clinical trial grant from AMS. In addition, all contribution in recruitment is acknowledged.

Funding

Initially supported by a clinical trial grant from AMS. After having stopped producing mesh products the study continued without funding. AMS was not involved in study setup, design, data acquisition, data analysis, data interpretation or editing of this study.

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Authors and Affiliations

Authors

Contributions

JM: Protocol/project development, data collection or management, data analysis, and manuscript writing/editing. CR: Protocol/project development, data collection or management, and manuscript writing/editing. TSM: Protocol/project development, data collection or management, and manuscript writing/editing. FS: Data collection or management, data analysis, and manuscript editing. RT: Protocol/project development, data collection or management, data analysis, and manuscript writing/editing. MH: Protocol/project development, data collection or management, data analysis, and manuscript writing/editing.

Corresponding author

Correspondence to Juliane Marschke.

Ethics declarations

Conflict of interest

Juliane Marschke: (speaker honorar) AMS, Astellas. Christl Reisenauer: (speaker honorar) Astellas, AMS, Allergan, Medtronic, Coloplast. Tomi S Mikkola: Unrestricted grant from Contura, speaker for Astellas and Mylan. Ralf Tunn: (speaker honorar) AMS, Astellas, Allergan, Promedon. Markus Huebner: None.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Marschke, J., Reisenauer, C., Mikkola, T.S. et al. Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial. Arch Gynecol Obstet 299, 1015–1022 (2019). https://doi.org/10.1007/s00404-019-05077-0

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  • DOI: https://doi.org/10.1007/s00404-019-05077-0

Keywords

  • Bladder inserter
  • Cough test
  • Operative variations
  • Retropubic sling
  • Stress urinary incontinence
  • Tension-free vaginal tape