A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence
| Autor: | Rosamaria Oppedisano, Pasquale Mastrantonio, Achille Tolino, Giovanni Battista La Sala, Caterina Materazzo, Luigi Alio, Antonio Maiorana, Angela Falbo, Stefano Palomba, Marco Torella, Fulvio Zullo, Nicola Colacurci |
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| Přispěvatelé: | Palomba, Stefano, Falbo, Angela, Oppedisano, Rosamaria, Torella, Marco, Materazzo, Caterina, Maiorana, Antonio, Tolino, Achille, Mastrantonio, Pasquale, La Sala, Giovanni Battista, Alio, Luigi, Colacurci, Nicola, Zullo, Fulvio |
| Rok vydání: | 2014 |
| Předmět: |
Cure rate
medicine.medical_specialty Aged Equipment Design Female Follow-Up Studies Humans Middle Aged Quality of Life Sexual Behavior Time Factors Treatment Outcome Urinary Incontinence Stress Suburethral Slings Tvt secur Urology Urinary incontinence law.invention Sling Primary outcome Randomized controlled trial law Medicine Single-incision minisling Surgical treatment Incontinence business.industry Obstetrics and Gynecology Treatment Sexual behavior Single incision Surgery medicine.symptom business |
| Zdroj: | International Urogynecology Journal. 25:1333-1341 |
| ISSN: | 1433-3023 0937-3462 |
| Popis: | 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. 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. 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]. The long-term efficacy of SIMS does not differ between the vaginal kits examined. |
| Databáze: | OpenAIRE |
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