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Prospective randomized trial comparing synthetic vs biological out-in transobturator tape: a mean 3-year follow-up study

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Abstract

Introduction and hypothesis

The aim of this study was to prospectively and randomly compare the outcome of surgical treatment of female stress urinary incontinence (SUI) using the same outside–inside transobturator technique with biological (PelviLaceTO®) or synthetic (UretexTO®) material sling, evaluating if the biological material can prevent vaginal erosion retaining the “cure rate” of this surgical technique.

Methods

Seventy patients with SUI were selected, randomly assigned to either UretexTO® (n = 34) or PelviLaceTO® (n = 36), and underwent the same surgery.

Results

There is no significant difference between two study arms with regard to objective and subjective cure rates and quality of life. In both groups we had an overlap cure rate (UretexTO® group 88.2% vs PelviLaceTO® group 88.8%) at mean 3 years follow-up. It found no perioperative complications nor vaginal erosions.

Conclusions

UretexTO® and PelviLaceTO® are two similarly safe and efficient slings in the management of SUI, with a good patient satisfaction and without any complications.

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Acknowledgements

We thank all patients who have placed their trust on us and allowed us to study, learn, and grow and Sandy Langford for her help with translation.

Integrity of research and reporting

The authors Raffaele Paparella, Monia Marturano, Laura Pelino, Alessandra Scarpa, Giovanni Scambia, Giuseppe La Torre, Pierluigi Paparella, qualify by having participated actively and sufficiently in the study reported. The authors give their final approval of the version of the manuscript being submitted. The authors confirm that all bylined authors fulfill all conditions.

Ethical standards

This human study has been approved by the appropriate ethics committee, and it has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. All persons gave their informed consent prior to their inclusion in the study.

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Association Columbus-Operative Unit of Urogynecology and Reconstructive Surgery of Pelvic Floor-Department for the Protection of the Health of Women and Rising Life, Catholic University of Sacred Heart, Via Giuseppe Moscati, 31, 00168, Rome, Italy

    Raffaele Paparella, Monia Marturano, Laura Pelino, Alessandra Scarpa & Pierluigi Paparella

  2. Obstetric and gynecological pathology-Department for the Protection of the Health of Women and Rising Life, Catholic University of Sacred Heart, Largo Agostino Gemelli, 1, 00168, Rome, Italy

    Giovanni Scambia

  3. Clinical Medicine and Public Health Unit, Sapienza University of Rome, Viale Regina Elene, 324-00161, Rome, Italy

    Giuseppe La Torre

Authors
  1. Raffaele Paparella
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  2. Monia Marturano
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  3. Laura Pelino
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  4. Alessandra Scarpa
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  5. Giovanni Scambia
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  6. Giuseppe La Torre
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  7. Pierluigi Paparella
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Corresponding author

Correspondence to Monia Marturano.

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Paparella, R., Marturano, M., Pelino, L. et al. Prospective randomized trial comparing synthetic vs biological out-in transobturator tape: a mean 3-year follow-up study. Int Urogynecol J 21, 1327–1336 (2010). https://doi.org/10.1007/s00192-010-1197-y

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  • DOI: https://doi.org/10.1007/s00192-010-1197-y

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