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Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial
Stefano Palomba1, Rosamaria Oppedisano2, Angela Falbo1
1Obstetrics 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.
Study 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).
Design:
Prospective multicenter cohort trial (registration number NCT00751088) (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 < .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).
Conclusion:
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.
