title: Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial.
abstract: OBJECTIVE
  To compare single-incision mini-slings (SIMSs) and retropubic tension-free vaginal tape (r-TVT) in terms of the long-term efficacy and safety for the treatment of female stress (SUI) or mixed urinary incontinence (MUI).
  
  
  METHODS
  Prospective multicenter cohort trial (registration number NCT00751088) (Canadian Task Force II).
  
  
  METHODS
  Department of Obstetrics and Gynecology, Italy.
  
  
  METHODS
  Two hundred-forty women with SUI/MUI.
  
  
  METHODS
  SIMS or r-TVT.
  
  
  RESULTS
  The operative time and the use of analgesic tablets were significantly (p < .001) higher and lower, respectively, in the r-TVT group versus the SIMS group. After 24 months of follow-up, no difference between the study arms was observed in terms of the complication rate (30/120 [25%] vs 19/120 [15.8%] for the r-TVT and SIMS arms, respectively; relative risk = 1.58; 95% confidence interval, 0.94-2.65; p = .083), whereas the subjective cure rate was significantly lower in the SIMS arm than in the r-TVT arm (57/103 [55.3%] vs 89/106 [84.0%] for the r-TVT and SIMS arms, respectively; relative risk = 0.66; 95% confidence interval, 0.54-0.80]; p < .001). The proportion of retreated patients for SUI/MUI was significantly higher in the SIMS arm than in the r-TVT arm (37/103 [34.9%] vs 12/106 [11.3%] for SIMS and r-TVT arm, respectively; p < .001).
  
  
  CONCLUSIONS
  SIMS has no advantage in terms of safety over r-TVT and was found to be less effective than r-TVT. Thus, its use in the clinical practice should be questioned.
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, University of Modena and Reggio Emilia, Reggio Emilia, Italy. Electronic address: stefanopalomba@tin.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Palomba
authors.affiliation: Departments of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
authors.forename: Rosamaria
authors.initials: R
authors.lastname: Oppedisano
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, University of Modena and Reggio Emilia, Reggio Emilia, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Falbo
authors.affiliation: Departments of Obstetrics and Gynecology, Second University of Naples, Naples, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Torella
authors.affiliation: Unit of Obstetrics and Gynecology, Hospital "Civico" of Palermo, Palermo, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Maiorana
authors.affiliation: Departments of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Materazzo
authors.affiliation: Department of Obstetrics and Gynecology, University "Federico II" of Naples, Naples, Italy.
authors.forename: Achille
authors.initials: A
authors.lastname: Tolino
authors.affiliation: Department of Obstetrics and Gynecology, University of Molise, Molise, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Mastrantonio
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, University of Modena and Reggio Emilia, Reggio Emilia, Italy.
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: La Sala
authors.affiliation: Unit of Obstetrics and Gynecology, Hospital "Civico" of Palermo, Palermo, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Alio
authors.affiliation: Departments of Obstetrics and Gynecology, Second University of Naples, Naples, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Colacurci
authors.affiliation: Departments of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Zullo
mesh_terms: D015331:Cohort Studies; D005260:Female; D006801:Humans; D007558:Italy; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D053825:Suburethral Slings / Q000009:adverse effects; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000295:instrumentation*
keywords: Clinical trial; Incontinence; Mini-slings; Single-incision; Sling; Surgery