EURURO Vol. 71 No. 4

675 692

1. Introduction
Stress urinary incontinence (SUI) is the predominant form
of urinary incontinence. Depending on age, the prevalence
ranges from 29–75%, with a mean of 48% . Several
surgical options for treating SUI, after failure of conserva-
tive measures, are available. According to the 2013 update
of the International Consultation on Incontinence guide-
lines, the surgical treatments of SUI may include the use of
bulking agents, midurethral slings (MUSs), and colposus-
pension . It has been widely demonstrated that MUSs
are the most effective and safe surgical procedures for the
management of SUI compared with other techniques
. Several randomized controlled trials showed that
transobturator insertion of a synthetic MUS gave equiva-
lent patient-reported and clinician-reported cure rates at
short- to medium-term follow-up compared with retro-
pubic insertion . Although the long-lasting benefits of
the retropubic route have been adequately evaluated ,
long-term outcomes for the transobturator route need to
be addressed.
Only six studies have assessed medium-term outcomes
of the tension-free vaginal tape–obturator (TVT-O)
procedure, with a maximum follow-up period of 5 yr
. In some of these studies, women with overactive
bladder (OAB) symptoms or with urodynamically proven
detrusor overactivity (DO) were included . To date,
the available evidence concerning long-term outcomes of
TVT-O is limited at two studies. In one of these, Athanasiou
et al reported subjective and objective cure rates of
124 TVT-O procedures at 7-yr follow-up of 83.5% and
81.5%, respectively; however, this retrospective analysis
included 93 procedures associated with concomitant
prolapse surgery. In the other prospective, multicenter
clinical trial 47 TVT-O procedures were evaluated
with median follow-up of 100 mo, and a subjective cure
rate of 59.6% and an objective cure rate of 70.2% were
found; the authors also considered women with mixed
urinary incontinence. We have published a prospective,
multicenter study to evaluate transobturator tape for the
treatment of SUI at 5-yr follow-up . The aim of the
present multicenter study is to report, for the first time in
the available literature to our knowledge, the long-term
objective and subjective outcomes of women with TVT-O
implantation for pure SUI with follow-up of 10 yr to
assess the efficacy and safety of this procedure in the case
of pure SUI.
2. Materials and methods
This was a multicenter, prospective study at five tertiary referral
centers in three countries. From January 2004, we have enrolled all
consecutive women with pure SUI symptoms with urodynamically
proven urodynamic stress incontinence (USI). All patients recom-
mended for surgery were scheduled for a TVT-O procedure (Gynecare
TVT Obturator System; Ethicon Inc., Somerville, NJ, USA). Exclusion
criteria were as follows: women with a history of radical pelvic
surgery, psychiatric or neurologic disorders, concomitant vaginal
prolapse greater than stage 1 according to the pelvic organ prolapse
(POP) quantification (POP-Q) system OAB symptoms, urodyna-
mically proven DO, and postvoid residual urine volume > 100 ml
Preoperative evaluation included medical history, physical exami-
nation, a voiding diary, urinalysis, and complete urodynamic testing.
Physical examination was performed with the patient in the lithotomy
position, and POP was described during a maximal Valsalva maneuver
according to the POP-Q system All women were evaluated by a
trained urogynecologist with urodynamic studies as previously
described (including uroflowmetry, filling cystometry, Valsalva
leak-point pressure [VLPP] measurement, and pressure/flow study),
using a standardized protocol in accordance with the good urodynamic
practice guidelines of the International Continence Society Ure-
thral hypermobility was defined by a Q-tip test result >308. Patients
were included regardless of Q-tip test results and VLPP values. All
methods, definitions, and units were updated in agreement with the
last version of the International Continence Society standardization of
terminology All patients also completed the International
Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF)
questionnaire
All the TVT-O procedures were performed according to the
technique originally described by De Leval using the inside-out
approach. The procedure uses a polypropylene sling with two arms
that are passed inside to outside through the obturator foramens,
pulled to compress the bulbar urethra upward, and tied to each other
across the midline. General or spinal anesthesia was used in
accordance with the anesthesiologic requirements and/or the patient’s
preference, as previously reported Postoperative evaluations
were mandatory at 12 mo, 60 mo, and 120 mo in all centers, and
intermediate visits were scheduled at the physician’s discretion. Every
follow-up visit included medical history, physical examination,
voiding diary, stress test, and evaluation of subjective satisfaction. A
stress test was performed in the lithotomy and upright positions with a
full bladder (ultrasonographic measurement 400 ml). Objective cure
was defined as the absence of urine leakage during the stress test. To
define the subjective outcomes at 1, 5, and 10 yr, all patients completed
the ICIQ-SF, the Patient Global Impression of Improvement (PGI-I)
scale (a 7-point scale, with a range of responses from 1, ‘‘very much
improved,’’ through 7, ‘‘very much worse’’) , and a patient
satisfaction scale (a single, self-answered, Likert-type scale of 0–10
that grades the patient’s degree of satisfaction regarding continence:
0 indicates ‘‘not satisfied,’’ and 10, ‘‘satisfied’’) Subjective success
was indicated both by ‘‘very much improved’’ or ‘‘much improved’’
(PGI-I score 2) and by a patient satisfaction score 8, as previously
described in 2011 by Abdel-Fattah et al .
The Declaration of Helsinki was followed, and preoperative written
informed consent for TVT-O implantation was obtained from all patients
in this observational prospective evaluation.
2.1. Statistical analysis
Statistical analysis was performed with IBM-SPSS v.17 for Windows (IBM
Corp, Armonk, NY, USA). Continuous variables were reported as median
and interquartile range. We used the x2 test and x2 test for trend to
analyze and compare the surgical outcomes during the follow-up. The x2
test for trend can better assess if the success of the surgical procedure
tends to decrease over time, comparing the cure rates at the different
follow-up visits (1, 5, and 10 yr). The null hypothesis is that there is not an
association between the cure rate of TVT-O and the time. One-way
analysis of variance was used to compare continuous series of variables in
the comparison of the scores used to measure the subjective outcomes.
The Cox proportional hazards model was used for univariate analysis to
evaluate factors potentially affecting the risk of recurrence (subjective or
objective) during the study period. Statistical significance was considered
achieved when p < 0.05.
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