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A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence

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Abstract

Introduction and hypothesis

Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up.

Methods

This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student’s t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure.

Results

We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference −0.6%, 95% CI −12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI −9 to 11%). Both procedures were associated with low complication rates.

Conclusions

After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.

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Acknowledgements

Valuable help in the collection of data was given by Leon Bos, medical student.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Spaarne Gasthuis, Boerhaavelaan 22, 2035 RC, Haarlem, The Netherlands

    René P. Schellart

  2. Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands

    Sandra E. Zwolsman & Jan-Paul W. R. Roovers

  3. Department of Obstetrics and Gynecology, Jeanne de Flandre Hôpital, Lille Cedex, France

    Jean-Philippe Lucot

  4. Department of Urology, University Hospitals Leuven, Leuven, Belgium

    Dirk J. M. K. de Ridder

  5. Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands

    Marcel G. W. Dijkgraaf

Authors
  1. René P. Schellart
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  2. Sandra E. Zwolsman
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  3. Jean-Philippe Lucot
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  4. Dirk J. M. K. de Ridder
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  5. Marcel G. W. Dijkgraaf
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  6. Jan-Paul W. R. Roovers
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Corresponding author

Correspondence to René P. Schellart.

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Funding

The trial was supported by an unrestricted research grant from ASTORA™ Women’s Health.

Disclosure statement

R.P. Schellart: ASTORA™ Women’s Health: grant/research support.

S.E. Zwolsman: Reports no conflicts of interest.

J.P. Lucot: Boston Scientific: surgical teaching sessions.

D.J.M.K. de Ridder: ASTORA™ Women’s Health: surgical teaching sessions, speaker.

M.G.W. Dijkgraaf: Reports no conflicts of interest.

J.P.W.R. Roovers: ASTORA™ Women’s Health: scientific medical advisor, grant/research support. Bard Medical: independent research grant. Coloplast: independent research grant.

Additional information

Ethical considerations and registration of clinical trial

The trial was registered with the Netherlands Trial Register (NTR3783; http://www.trialregister.nl/trialreg/index.asp) and was approved by the medical ethics committees of all participating centers (MEC numbers B32220107859; F 201-A00147-32; NL28973.018.09).

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Schellart, R.P., Zwolsman, S.E., Lucot, JP. et al. A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence. Int Urogynecol J 29, 37–44 (2018). https://doi.org/10.1007/s00192-017-3362-z

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  • DOI: https://doi.org/10.1007/s00192-017-3362-z

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