EURURO Vol. 71 No. 4

Incontinence

Tension-free Vaginal Tape–Obturator for Treatment of Pure

Urodynamic Stress Urinary Incontinence:

Efficacy and Adverse Effects at 10-year Follow-up

Maurizio Serati

a , * ,

Andrea Braga

b ,

Stavros Athanasiou

c ,

Giovanni

[1_TD$DIFF]

A. Tommaselli

d ,

Giorgio Caccia

b ,

Marco Torella

e ,

Fabio Ghezzi

a ,

Stefano Salvatore

Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy;

Department of Obstetrics and Gynecology, EOC–Beata Vergine Hospital,

Mendrisio, Switzerland;

First Department of Obstetrics and Gynecology, University of Athens, ‘‘Alexandra’’ Hospital, Athens, Greece;

Department of

Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy;

Department of Obstetrics and Gynecology, Second Faculty, Naples, Italy;

Obstetrics and Gynecology Unit, Vita-Salute University and IRCCS San Raffaele Hospital, Milan, Italy

E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) 6 7 4 – 6 7 9

available at

www.scienced irect.com

journal homepage:

www.europeanurology.com

Article info

Article history:

Accepted August 23, 2016

Associate Editor:

Christian Gratzke

Keywords:

Long-term follow-up

Sling

Stress urinary incontinence

Tension-free vaginal tape-

obturator

TVT-O

Urinary incontinence

Abstract

Background:

Inside-out transobturator tape (tension-free vaginal tape–obturator [TVT-

O]) is currently one of the most effective and popular procedures for the surgical

treatment of female stress urinary incontinence (SUI). However, data reporting long-

term outcomes are lacking.

Objective:

To assess the efficacy and safety of TVT-O 10 yr after implantation for the

treatment of female pure SUI.

Design, setting, and participants:

A multicenter, prospective study was conducted in

five tertiary referral centers in three countries. All consecutive women with urodyna-

mically proven pure SUI treated by TVT-O were included. Patients with mixed inconti-

nence and/or anatomic evidence of pelvic organ prolapse were excluded.

Intervention:

TVT-O implantation.

Outcome measurements and statistical analysis:

Data regarding subjective outcomes

(International Consultation on Incontinence Questionnaire–Short Form, Patient Global

Impression of Improvement, and patient satisfaction scores), objective cure (stress test)

rates, and adverse events were collected during follow-up. Univariable analysis was

performed to investigate outcomes.

Results and limitations:

One hundred sixty-eight women had TVT-O implantation. At

10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find

any significant change of the surgical outcomes during this time. At 10 yr after surgery,

155 of 160 patients (97%) declared themselves cured (

= 0.7). Similarly, at 10-yr

evaluation, 148 of 160 patients (92%) were objectively cured. No significant deteriora-

tion of objective cure rates was observed over time (

= 0.4). The history of failure of

previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61–11.9;

= 0.009)

was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was

reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications

were reported.

Conclusions:

The 10-yr results of this study showed that TVT-O is a highly effective and

safe option for the treatment of SUI.

Patient summary:

At long-term follow up, tension-free vaginal tape-obturator is highly

effective and safe for the treatment of stress urinary incontinence.

* Corresponding author. Department of Obstetrics and Gynecology, Urogynecology Unit, University

of Insubria, Piazza Biroldi 1, 21100 Varese, Italy. Tel. +39 0332 299 309; Fax: +39 0332 299 307.

E-mail address:

mauserati@hotmail.com

(M. Serati).

http://dx.doi.org/10.1016/j.eururo.2016.08.054

0302-2838/