Format

Send to

Choose Destination
J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):303-10. doi: 10.1016/j.jmig.2013.08.714. Epub 2013 Oct 19.

Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial.

Author information

1
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.
2
Departments of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
3
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.
4
Departments of Obstetrics and Gynecology, Second University of Naples, Naples, Italy.
5
Unit of Obstetrics and Gynecology, Hospital "Civico" of Palermo, Palermo, Italy.
6
Department of Obstetrics and Gynecology, University "Federico II" of Naples, Naples, Italy.
7
Department of Obstetrics and Gynecology, University of Molise, Molise, Italy.

Abstract

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.

KEYWORDS:

Clinical trial; Incontinence; Mini-slings; Single-incision; Sling; Surgery

PMID:
24148568
DOI:
10.1016/j.jmig.2013.08.714
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center