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Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial

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Abstract

Background

We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women.

Study design

The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O.

Results

A total of 480 patients (85 %) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87 % of patients after TVT and in 84 % after TVT-O; 64 % and 59 % of patients, respectively, reported no pad use, and 88 % of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings’ Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications.

Conclusions

Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

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Acknowledgments

We gratefully acknowledge the following participating centers and investigators: Geburtshilflich-gynäkologische Univ.-Klinik Graz (T. Aigmüller, K. Tamussino, V. Bjelic-Radisic, A. Giuliani, E. Greimel, J. Haas); Wilhelminenspital Wien (A. Tammaa, A. Mirna, R. Novak, B. Reichetzer, H. Salzer); Univ.-Frauenklinik Wien (E. Hanzal, W. Umek, K. Elenskaia); Univ.-Frauenklinik Innsbruck (D. Kölle, S. Kropshofer); LKH Mödling (A. Dungl, S. Hinterholzer, P. Riss); LKH Leoben (G. Müller, G. Ralph); Krankenhaus der Barmherzigen Brüder Graz (P. Lang, E. Gruber-Fröhlich, O. Preyer, E. Rothe); LKH Klagenfurt (K. Fabel, G. Mori); Krankenhaus der Barmherzigen Brüder Wien (G. Wagner); LKH Wiener Neustadt (C. Gamper, R. Schacherl); Krankenhaus der Barmherzigen Schwestern Linz (J. Angleitner, G. Hartmann); Krankenhaus Amstetten (K. Weghaupt); LKH Bad Ischl (A. Bichler); LKH Judenburg (M. Börecz, P. Klug); LKH Dornbirn (W. Neunteufel); LKH Wels (H.J. Huemer, K. Reisenberger); LKH Feldbach (M. Konrad, H.M.H. Hofmann); Krankenhaus der Barmherzigen Brüder St. Veit (A. Roth, F. Ronaghi); LKH Gmunden (E, Kostersitz, G. Hartmann); BKH Schwaz (D. Kölle); Donauspital Wien (K. Philipp); KH Korneuburg (P. Safar); Hanusch KH (M. Medl, D. Uhl); Amper-Klinikum Dachau (U. Peschers, G. Debus); Klinik für Frauenheilkunde/Campus Innenstadt, University of Munich (K. Jundt).

Financial support

Austrian Urogynecology Working Group

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Department of Obstetrics & Gynecology, Medical University of Graz, Auenbruggerplatz 14, A-8036, Graz, Austria

    Thomas Aigmüller, Karl Tamussino, Vesna Bjelic-Radisic, Josef Haas & Albrecht Giuliani

  2. Department of Obstetrics & Gynecology, Wilhelminenspital, Vienna, Austria

    Ayman Tammaa

  3. Department of Obstetrics & Gynecology, Medical University of Vienna, Vienna, Austria

    Engelbert Hanzal & Wolfgang Umek

  4. Department of Obstetrics & Gynecology, Medical University of Innsbruck, Innsbruck, Austria

    Dieter Kölle & Stephan Kropshofer

  5. Department of Gynecology, Krankenhaus der Barmherzigen Brüder, Graz, Austria

    Peter F. J. Lang & Oliver Preyer

  6. Department of Obstetrics & Gynecology, Amper-Klinikum Dachau, Dachau, Germany

    Ursula Peschers

  7. Department of Obstetrics & Gynecology, University of Munich, Munich, Germany

    Katharina Jundt

  8. Department of Obstetrics & Gynecology, Landeskrankenhaus Leoben, Leoben, Austria

    George Ralph

  9. Department of Obstetrics & Gynecology, Landeskrankenhaus Mödling, Mödling, Austria

    Andrea Dungl & Paul A. Riss

Authors
  1. Thomas Aigmüller
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  2. Ayman Tammaa
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  3. Karl Tamussino
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  4. Engelbert Hanzal
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  5. Wolfgang Umek
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  6. Dieter Kölle
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  7. Stephan Kropshofer
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  8. Vesna Bjelic-Radisic
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  9. Josef Haas
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  10. Albrecht Giuliani
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  11. Peter F. J. Lang
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  12. Oliver Preyer
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  13. Ursula Peschers
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  14. Katharina Jundt
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  15. George Ralph
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  16. Andrea Dungl
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  17. Paul A. Riss
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Consortia

for the Austrian TVT vs. TVT-O Study Group

Corresponding author

Correspondence to Karl Tamussino.

Additional information

Drs. Aigmüller and Tammaa contributed equally to this manuscript.

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Aigmüller, T., Tammaa, A., Tamussino, K. et al. Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial. Int Urogynecol J 25, 1023–1030 (2014). https://doi.org/10.1007/s00192-014-2384-z

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  • DOI: https://doi.org/10.1007/s00192-014-2384-z

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