TY - JOUR
T1 - A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence
T2 - Surgical data
AU - Palomba, Stefano
AU - Oppedisano, Rosamaria
AU - Torella, Marco
AU - Falbo, Angela
AU - Maiorana, Antonio
AU - Materazzo, Caterina
AU - Tartaglia, Eduardo
AU - Tolino, Achille
AU - Mastrantonio, Pasquale
AU - Alio, Luigi
AU - Colacurci, Nicola
AU - Zullo, Fulvio
PY - 2012/7
Y1 - 2012/7
N2 - 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.
AB - 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.
KW - Ajust
KW - Miniarc
KW - Minislings
KW - Single incision device
KW - Stress incontinence
KW - TVT Secur System
KW - Urinary incontinence
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U2 - 10.1016/j.ejogrb.2012.03.038
DO - 10.1016/j.ejogrb.2012.03.038
M3 - Article
C2 - 22552180
AN - SCOPUS:84862174571
VL - 163
SP - 108
EP - 112
JO - European Journal of Obstetrics, Gynecology and Reproductive Biology
JF - European Journal of Obstetrics, Gynecology and Reproductive Biology
SN - 0028-2243
IS - 1
ER -