TY - JOUR
T1 - A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence
AU - Palomba, Stefano
AU - Falbo, Angela
AU - Oppedisano, Rosamaria
AU - Torella, Marco
AU - Materazzo, Caterina
AU - Maiorana, Antonio
AU - Tolino, Achille
AU - Mastrantonio, Pasquale
AU - La Sala, Giovanni Battista
AU - Alio, Luigi
AU - Colacurci, Nicola
AU - Zullo, Fulvio
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Incontinence
KW - Randomized controlled trial
KW - Single-incision minislings
KW - Sling
KW - Surgery
KW - Treatment
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U2 - 10.1007/s00192-014-2383-0
DO - 10.1007/s00192-014-2383-0
M3 - Article
C2 - 24737301
AN - SCOPUS:84939897370
VL - 25
SP - 1333
EP - 1341
JO - International Urogynecology Journal and Pelvic Floor Dysfunction
JF - International Urogynecology Journal and Pelvic Floor Dysfunction
SN - 0937-3462
IS - 10
ER -