STUDY OBJECTIVE: To compare single-incision mini-slings (SIMS) 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).
DESIGN: Prospective multicenter cohort trial (registration number NCT00751088).
DESIGN CLASSIFICATION: Canadian Task Force - II.
SETTINGS: Department of Obstetrics and Gynecology, Italy.
PATIENTS: Two hundred-forty women with SUI/MUI.
INTERVENTIONS: SIMS or r-TVT.
MEASUREMENTS AND MAIN RESULTS: The operative time and the use of analgesic tablets were significantly (P< 0.001) higher and lower, respectively, in the r-TVT group vs. 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 (RR) 1.58; 95% coefficient interval [CI] 0.94 to 2.65; P=0.083), 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; RR 0.66 [95%CI 0.54 to 0.80]; P< 0.001). 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< 0.001).
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.
Written by:
Palomba S, Oppedisano R, Falbo A, Torella M, Maiorana A, Materazzo C, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F. Are you the author?
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, Italy.
Reference: J Minim Invasive Gynecol. 2013 Oct 19. pii: S1553-4650(13)01292-2.
doi: 10.1016/j.jmig.2013.08.714
PubMed Abstract
PMID: 24148568
UroToday.com Stress Urinary Incontinence Section
