EURURO Vol. 71 No. 4

678 692

study, the authors assessed 145 consecutive women who
underwent a TVT-O procedure with or without concomitant
pelvic floor reconstructive surgery. In fact, they found that
women with central compartment prolapse and those
undergoing concomitant vaginal hysterectomy showed a
higher risk of subjective failure. In a prospective, multicen-
ter randomized clinical trial comparing TVT and TOT,
Costantini et al reported subjective and objective cure
rates of 59% and 70% among 47 patients included in the TOT
group, with median follow-up of 99 mo. A limitation of this
randomized trial could be that women with mixed urinary
incontinence were included, which probably influenced the
reported cure rates.
For the first time in the published literature to our
knowledge, we present subjective and clinically objective
10-yr follow-up after TVT-O in a multicenter study
including a large population of patients with only pure
SUI and USI. It is noteworthy that our findings showed a 10-
yr cure rate that is comparable to those reported for the TVT
procedure in various studies with much longer follow-up
. We have also considered several preoperative,
demographic, anamnestic, and clinical characteristics to
identify which factors could be involved in the risk of
failure, including the surgeon’s skill in this analysis. No
homogeneous data are available in the literature on the
different possible factors (obesity, VLPP, maximum urethral
closure pressure, fixed urethra, previous anti-incontinence
surgery) predictive of sling failure. In our popula-
tion, history of failure of previous anti-incontinence
procedures was the only independent predictor for objec-
tive and subjective 10-yr TVT-O failure. The onset of de novo
OAB symptoms, or their progression, is one of the most
clinically significant and largely debated postoperative
complications of MUSs. Previously published studies have
reported de novo urgency rates ranging from 4–33% after
retropubic TVT , but very few medium- or long-term
data are available on the relation between TVT-O and de
novo OAB symptom onset. In the long run, a relevant
percentage of women may naturally develop age-related
OAB symptoms, and this could play a confounding role. In
our previous study, we reported 5-yr onset of de novo OAB
symptoms in 24% of patients at 1-yr follow-up and 19% of
patients at 5-yr follow-up . In the present study, at 10 yr
after TVT-O, we recorded a considerable reduction in the
prevalence of de novo OAB (14%). This is important for
preoperative counseling because the presence of postoper-
ative OAB symptoms has a relevant effect on patient
satisfaction and health-related quality of life after sling
surgery. Furthermore, compared with previous long-series
MUS outcomes the high trends of subjective and
objective cure rates were maintained over time.
Points of strength of this study are the following: (1) it
was a multicenter study; (2) it used a highly homogeneous
study population with the exclusion of women with mixed
incontinence, preoperative DO, and/or any other associated
surgical procedure; (3) the subjective and objective out-
comes were obtained using validated tools; and (4) the rate
of loss to follow-up was very low. Conversely, we
acknowledge that a limitation of this study could be that
formal, validated quality-of-life questionnaires were not
used because, unfortunately, no validated quality-of-life
questionnaire exists in Italian. In the present study and the
previous studies, we used the standardized and validated
ICIQ-SF, the Urogenital Distress Inventory Short Form, and
two validated patient satisfaction scales to evaluate results
of the classic retropubic TVT and TVT-O
5. Conclusions
The 10-yr results of this study showed that TVT-O is a highly
effective and safe option for the treatment of female SUI.
The objective and subjective cure rates were both very high.
We did not find any late adverse effect related to this
procedure.
Author contributions: Maurizio Serati had full access to all the data in the
study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Serati.
Acquisition of data: Serati, Braga, Athanasiou, Tommaselli, Torella,
Salvatore.
Analysis and interpretation of data: Serati, Braga.
Drafting of the manuscript: Serati, Braga.
Critical revision of the manuscript for important intellectual content: Caccia,
Ghezzi, Salvatore.
Statistical analysis: Serati.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: None.
Other (specify): None.
Financial disclosures: Maurizio Serati certifies that all conflicts of
interest, including specific financial interests and relationships and
affiliations relevant to the subject matter or materials discussed in the
manuscript (eg, employment/affiliation, grants or funding, consultan-
cies, honoraria, stock ownership or options, expert testimony, royalties,
or patents filed, received, or pending), are the following: Tommaselli has
been an employee of Johnson & JohnsonMedical since March 1, 2016. His
contribution to the present study is antecedent to his employment with
Johnson & Johnson Medical and was not influenced by his present
position. At the time of the study, Tommaselli was a consultant for Solace
Therapeutics and Johnson & Johnson Medical.
Funding/Support and role of the sponsor: None.
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