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AdVanceXP male sling: 2-year results of a multicentre study

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World Journal of Urology Aims and scope Submit manuscript

Abstract

Purpose

For the treatment of persistent post-prostatectomy incontinence (PPI), several surgical treatment options including male slings are available. In 2010, the second generation of the retrourethral male sling Advance, AdVanceXP, was introduced. Aim of the study was to examine in a prospective multicentre study the outcome of AdVanceXP in the treatment of PPI.

Methods

Ninety-four patients were treated with AdVanceXP. Patients with nocturnal incontinence, previous incontinence surgery, with coaptive zone <1 cm and irradiated patients were excluded. Measurements included: daily pad usage, 24-h pad weight test, post-operative pain in the visual analogue scale, International Quality of Life questionnaire, International Consultation on Incontinence Questionnaire short form, IEEF5 and Patient Global Impression of Improvement. Adverse events were recorded. All patients with no pads and 0–5 g in the 24-h pad test were defined as cured and those with a reduction in urine loss >50 % as improved.

Results

Preoperatively, the median 24-h pad weight test was 274 g and daily pad usage was 3. At 1-year follow-up, 66.3 % of patients could be classified as cured and 25.3 % as improved. After 2 years, 73.1 % could be classified as cured and 19.6 % as improved. Urine loss decreased (p < 0.001), and quality of life improved significantly (p < 0.001). Mean PGI was 1.5 after 1 year and 1.4 after 2 years. Majority of complications were minor. No intraoperative complications and five serious post-operative events occurred (grade IIIB complications). No explantation was necessary.

Conclusions

AdVanceXP, when correctly indicated, shows good effectiveness and low complication rates after up to 2 years.

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Acknowledgments

This study was sponsored by a Grant of American Medical Systems.

Authors’ contribution

Bauer involved in protocol development, data management and data analysis and wrote and edited the manuscript. Kretschmer involved in data collection, data management and data analysis and edited the manuscript. Gozzi involved in protocol development and edited the manuscript. Klehr involved in data collection and data analysis. Grabbert involved in data collection and data analysis and edited the manuscript. Rehder involved in protocol development and edited the manuscript. May involved in protocol development and edited the manuscript. Stief edited the manuscript. Gebhartl involved in protocol development and edited the manuscript. Homberg involved in protocol development and edited the manuscript.

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Correspondence to Ricarda M. Bauer.

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Conflicts of interest

Ricarda M. Bauer declares lectures, consultancy work and participation in clinical trials for AMS. Christian Gozzi and Peter Rehder are the co-inventors of the procedure but do not hold intellectual property (owned by American Medical Systems, USA). Christian Gozzi declares lectures, consultancy work and participation in clinical trials for AMS. Peter Rehder declares lectures, consultancy work and participation in clinical trials for AMS. Roland Homberg declares lectures and consultancy work for AMS. All other authors have no conflict of interest. All authors had full control of the primary data, and no agreement has limited their ability to fairly complete and publish the data.

Ethical standards

The study has been approved by all ethics committees participating in this study and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Informed consent

All patients gave their informed consent prior to their inclusion in the study.

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Bauer, R.M., Gozzi, C., Klehr, B. et al. AdVanceXP male sling: 2-year results of a multicentre study. World J Urol 34, 1025–1030 (2016). https://doi.org/10.1007/s00345-015-1731-0

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  • DOI: https://doi.org/10.1007/s00345-015-1731-0

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