Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes: A Multicenter Clinical Trial

Stefano Palomba, Rosamaria Oppedisano, Angela Falbo, Marco Torella, Antonio Maiorana, Caterina Materazzo, Achille Tolino, Pasquale Mastrantonio, Giovanni B. La Sala, Luigi Alio, Nicola Colacurci, Fulvio Zullo

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)303-310
Number of pages8
JournalJournal of Minimally Invasive Gynecology
Volume21
Issue number2
DOIs
Publication statusPublished - Mar 2014

Fingerprint

Suburethral Slings
Multicenter Studies
Clinical Trials
Urinary Incontinence
Confidence Intervals
Safety
Hospital Obstetrics and Gynecology Department
Advisory Committees
Operative Time
Gynecology
Italy
Tablets
Analgesics

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Medicine(all)

Cite this

Palomba, S., Oppedisano, R., Falbo, A., Torella, M., Maiorana, A., Materazzo, C., ... Zullo, F. (2014). Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes: A Multicenter Clinical Trial. Journal of Minimally Invasive Gynecology, 21(2), 303-310. https://doi.org/10.1016/j.jmig.2013.08.714

Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes : A Multicenter Clinical Trial. / Palomba, Stefano; Oppedisano, Rosamaria; Falbo, Angela; Torella, Marco; Maiorana, Antonio; Materazzo, Caterina; Tolino, Achille; Mastrantonio, Pasquale; La Sala, Giovanni B.; Alio, Luigi; Colacurci, Nicola; Zullo, Fulvio.

In: Journal of Minimally Invasive Gynecology, Vol. 21, No. 2, 03.2014, p. 303-310.

Research output: Contribution to journalArticle

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 2014, 'Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes: A Multicenter Clinical Trial', Journal of Minimally Invasive Gynecology, vol. 21, no. 2, pp. 303-310. https://doi.org/10.1016/j.jmig.2013.08.714
Palomba, Stefano ; Oppedisano, Rosamaria ; Falbo, Angela ; Torella, Marco ; Maiorana, Antonio ; Materazzo, Caterina ; Tolino, Achille ; Mastrantonio, Pasquale ; La Sala, Giovanni B. ; Alio, Luigi ; Colacurci, Nicola ; Zullo, Fulvio. / Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes : A Multicenter Clinical Trial. In: Journal of Minimally Invasive Gynecology. 2014 ; Vol. 21, No. 2. pp. 303-310.
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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.",
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