A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: Surgical data

Stefano Palomba, Rosamaria Oppedisano, Marco Torella, Angela Falbo, Antonio Maiorana, Caterina Materazzo, Eduardo Tartaglia, Achille Tolino, Pasquale Mastrantonio, Luigi Alio, Nicola Colacurci, Fulvio Zullo

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting. Study design: One hundred and twenty patients with SUI were randomized to receive three SIMS: Ajust ®, MiniArc ®, and TVT Secur System ®. Surgical data were compared. Results: Significantly (P <0.05) lower surgical difficulty and higher patient satisfaction were detected in the MiniArc ® group when compared to the Ajust ® and TVT Secur System ® groups. A significantly (P <0.05) higher feasibility under local anesthesia and in ambulatory setting was also detected for the MiniArc ® group. The overall complication rate was significantly (P <0.05) lower in the MiniArc ® group than in the TVT Secur System ® group. Conclusions: MiniArc ® is simpler to insert under local anesthesia and in an ambulatory setting. It is safer than the TVT Secur System ®, and is related to higher patient satisfaction.

Original languageEnglish
Pages (from-to)108-112
Number of pages5
JournalEuropean Journal of Obstetrics and Gynecology and Reproductive Biology
Volume163
Issue number1
DOIs
Publication statusPublished - Jul 2012

Keywords

  • Ajust
  • Miniarc
  • Minislings
  • Single incision device
  • Stress incontinence
  • TVT Secur System
  • Urinary incontinence

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Reproductive Medicine

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