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Randomized trial of graft materials in transobturator tape operation: biological versus synthetic

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Abstract

Objective

To compare the outcome of outside–in biological and synthetic transobturator tape (TOT) operation, including subjective and objective success rates, urodynamics, and quality of life.

Materials and methods

One hundred patients suffering from clinical and/or urodynamic stress urinary incontinence (SUI) were randomized into biological material TOT (PELVILACE® TO) or synthetic material TOT (ALIGN®TO Urethral Support System) groups. Preoperative and at 1 year postoperative urogynecological symptom assessment, 1-h pad test, 4-day bladder diary, stress test, Q-tip test, and urodynamics were performed. For the evaluation of quality of life, the King’s Health Questionnaire, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and Prolapse Quality of Life were used.

Results

There was no significant difference between the two groups regarding objective and subjective cure rates and quality of life. At 1-year follow-up, the subjective cure rate was 68 % in the biological material TOT and 70 % in the synthetic material TOT group. No perioperative complications developed. Groin pain developed in 2 patients in the biological TOT group and 1 patient had dehiscence in the periurethral incision, which healed with local estrogen. Two patients had transient urinary retention in the synthetic TOT group, 1 patient developed groin pain, and 1 patient had mesh erosion observed at the 1-year follow-up.

Conclusion

Transobturator tape with biological material in the management of SUI has a rate of success and patient satisfaction similar to those of synthetic material at 1-year follow-up. Studies with longer follow-up and larger cohorts are necessary to evaluate possible autolysis and degradation of biological slings and a possible reduction in efficacy over time.

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Acknowledgements

The authors would like to convey sincere gratitude to the Scientific Research Projects Coordination Unit of Istanbul University for the financial support.

Conflicts of interest

None.

Funding statement

This work was supported by the Scientific Research Projects Coordination Unit of Istanbul University.

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Authors and Affiliations

  1. Division of Urogynecology, Department of Obstetrics and Gynecology, Istanbul Medical School, Istanbul University, Atakoy 9. Kisim B6 Blok D40, 34156, Istanbul, Turkey

    Funda Gungor Ugurlucan, Habibe Ayyildiz Erkan, Murat Onal & Onay Yalcin

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  1. Funda Gungor Ugurlucan
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  2. Habibe Ayyildiz Erkan
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  3. Murat Onal
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Correspondence to Funda Gungor Ugurlucan.

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Ugurlucan, F.G., Erkan, H.A., Onal, M. et al. Randomized trial of graft materials in transobturator tape operation: biological versus synthetic. Int Urogynecol J 24, 1315–1323 (2013). https://doi.org/10.1007/s00192-012-2008-4

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  • DOI: https://doi.org/10.1007/s00192-012-2008-4

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