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

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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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Acknowledgments

The authors thank Jacqueline Costa of the Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico of Reggio Emilia (Italy) for language revision and assistance.

Conflicts of interest

None.

Funding

The current study was designed and performed thanks to departmental funds only.

Author information

Authors and Affiliations

  1. Obstetrics and Gynecology Unit, Department of Obstetrics, Gynecology and Pediatrics, Azienda Ospedaliera “Santa Maria Nuova” - Istituto di Ricovero e Cura a Carattere Scientifico of Reggio Emilia, Reggio Emilia, Italy

    Stefano Palomba, Angela Falbo & Giovanni Battista La Sala

  2. Departments of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro, Catanzaro, Italy

    Rosamaria Oppedisano, Caterina Materazzo & Fulvio Zullo

  3. Departments of Obstetrics & Gynecology, Second University of Naples, Naples, Italy

    Marco Torella & Nicola Colacurci

  4. Unit of Obstetrics & Gynecology, Hospital “Civico” of Palermo, Palermo, Italy

    Antonio Maiorana & Luigi Alio

  5. Department of Obstetrics & Gynecology, University “Federico II” of Naples, Naples, Italy

    Achille Tolino

  6. Department of Obstetrics & Gynecology, University of Molise, Campobasso, Italy

    Pasquale Mastrantonio

  7. University of Modena and Reggio Emilia, Modena, Italy

    Giovanni Battista La Sala

  8. Unit of Obstetrics & Gynecology, Azienda Ospedaliera “Santa Maria Nuova”, Via Risorgimento 80, 42123, Reggio Emilia, Italy

    Stefano Palomba

Authors
  1. Stefano Palomba
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  2. Angela Falbo
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  3. Rosamaria Oppedisano
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  4. Marco Torella
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  5. Caterina Materazzo
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  6. Antonio Maiorana
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  7. Achille Tolino
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  8. Pasquale Mastrantonio
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  9. Giovanni Battista La Sala
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  10. Luigi Alio
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  11. Nicola Colacurci
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  12. Fulvio Zullo
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Consortia

The SIMS Italian Group

Corresponding author

Correspondence to Stefano Palomba.

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Palomba, S., Falbo, A., Oppedisano, R. et al. A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence. Int Urogynecol J 25, 1333–1341 (2014). https://doi.org/10.1007/s00192-014-2383-0

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  • DOI: https://doi.org/10.1007/s00192-014-2383-0

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