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01.10.2014 | Original Article

A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence

verfasst von: Stefano Palomba, Angela Falbo, Rosamaria Oppedisano, Marco Torella, Caterina Materazzo, Antonio Maiorana, Achille Tolino, Pasquale Mastrantonio, Giovanni Battista La Sala, Luigi Alio, Nicola Colacurci, Fulvio Zullo, The SIMS Italian Group

Erschienen in: International Urogynecology Journal | Ausgabe 10/2014

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Abstract

Introduction and hypothesis

Studies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes.

Methods

One hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust^®, MiniArc^®, or TVT Secur System^®). Duration of follow-up was at least 24 months from surgery. The primary outcome was the subjective cure rate at 24 months from surgery; secondary outcomes were rates of total failure and reoperations for UI.

Results

At study end, no difference was detected between groups in terms of total subjective cure rate [21 (52.5 %) vs. 26 (65.0 %) vs. 21 (52.5 %), in Ajust^®, MiniArc^®, and TVT Secur System^® group, respectively; P = 0.412] or in terms of total failure rate [24 (60.0 %) vs. 22 (55.0 %) vs. 27 (67.5 %), in Ajust^®, MiniArc^®, and TVT Secur System^® group, respectively; P = 0.432]. The proportion of patients who received a second surgery for UI was also not significantly different between groups [13 (32.5 %) vs. 10 (25.0 %) vs. 13 (32.5 %), in Ajust^®, MiniArc^®, and TVT Secur System^®, respectively; P = 0.831].

Conclusion

The long-term efficacy of SIMS does not differ between the vaginal kits examined.

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Titel: A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence
verfasst von: Stefano Palomba
Angela Falbo
Rosamaria Oppedisano
Marco Torella
Caterina Materazzo
Antonio Maiorana
Achille Tolino
Pasquale Mastrantonio
Giovanni Battista La Sala
Luigi Alio
Nicola Colacurci
Fulvio Zullo
The SIMS Italian Group
Publikationsdatum: 01.10.2014
Verlag: Springer London
Erschienen in: International Urogynecology Journal / Ausgabe 10/2014
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-014-2383-0

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A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence