title: A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.
abstract: OBJECTIVE
  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].
  
  
  CONCLUSIONS
  The long-term efficacy of SIMS does not differ between the vaginal kits examined.
authors.affiliation: 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, stefanopalomba@tin.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Palomba
authors.forename: Angela
authors.initials: A
authors.lastname: Falbo
authors.forename: Rosamaria
authors.initials: R
authors.lastname: Oppedisano
authors.forename: Marco
authors.initials: M
authors.lastname: Torella
authors.forename: Caterina
authors.initials: C
authors.lastname: Materazzo
authors.forename: Antonio
authors.initials: A
authors.lastname: Maiorana
authors.forename: Achille
authors.initials: A
authors.lastname: Tolino
authors.forename: Pasquale
authors.initials: P
authors.lastname: Mastrantonio
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: La Sala
authors.forename: Luigi
authors.initials: L
authors.lastname: Alio
authors.forename: Nicola
authors.initials: N
authors.lastname: Colacurci
authors.forename: Fulvio
authors.initials: F
authors.lastname: Zullo
mesh_terms: D000368:Aged; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D012725:Sexual Behavior; D053825:Suburethral Slings; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000150:complications / Q000523:psychology / Q000601:surgery*
references.citation: Ann Intern Med. 2008 Feb 19;148(4):295-309
references.pmid: 18283207
references.citation: Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):115-21
references.pmid: 22917936
references.citation: Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9
references.pmid: 9422015
references.citation: Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):108-12
references.pmid: 22552180
references.citation: J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):303-10
references.pmid: 24148568
references.citation: Eur J Obstet Gynecol Reprod Biol. 2013 Jun;168(2):231-5
references.pmid: 23582403
references.citation: Eur Urol. 2012 Oct;62(4):737-8
references.pmid: 22795660
references.citation: Int Urogynecol J. 2013 Sep;24(9):1459-65
references.pmid: 23208003
references.citation: Med Care. 1992 Jun;30(6):473-83
references.pmid: 1593914
references.citation: Acta Obstet Gynecol Scand. 2012 Aug;91(8):901-10
references.pmid: 22497363
references.citation: J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208
references.pmid: 10782451
references.citation: Am J Obstet Gynecol. 2003 Jul;189(1):98-101
references.pmid: 12861145
references.citation: Urology. 2010 May;75(5):1060-4
references.pmid: 20223506
references.citation: Eur Urol. 2014 Feb;65(2):402-27
references.pmid: 24055431
references.citation: Eur Urol. 2010 Jun;57(6):973-9
references.pmid: 20206437
references.citation: Acta Obstet Gynecol Scand. 1982;61(2):137-41
references.pmid: 7113688
references.citation: J Urol. 2011 Apr;185(4):1356-62
references.pmid: 21334682
references.citation: Int J Gynaecol Obstet. 2010 Dec;111(3):233-6
references.pmid: 20822770
references.citation: Eur Urol. 2011 Jun;59(6):940-4
references.pmid: 21277076
references.citation: Eur Urol. 2014 Feb;65(2):428-9
references.pmid: 24035681
references.citation: Clin Obstet Gynecol. 1972 Dec;15(4):1048-54
references.pmid: 4649139
references.citation: Clin Cancer Res. 2008 Jul 15;14(14):4368-71
references.pmid: 18628449
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jan;19(1):5-33
references.pmid: 18026681
references.citation: Obstet Gynecol. 1988 Jun;71(6 Pt 1):807-11
references.pmid: 3368164
references.citation: Eur Urol. 2011 Sep;60(3):468-80
references.pmid: 21621321
references.citation: Obstet Gynecol. 2012 Feb;119(2 Pt 1):328-37
references.pmid: 22270285
references.citation: Ann Intern Med. 2010 Jun 1;152(11):726-32
references.pmid: 20335313
references.citation: J Urol. 2012 Jul;188(1):194-9
references.pmid: 22591959