Introduction
Urinary incontinence (UI) is a common condition that affects 35 -50 %
of women during their lifetime1. Patients with UI have
a significantly poorer quality of life than their continent
counterparts2. Stress urinary incontinence (SUI)
represents the most common UI type, and its pathophysiology has
consistently improved during the past two decades. Based on the integral
theory of continence, Petros and Ulmsten in 1995 proposed their
mid-urethral sling concept and introduced the original retropubic
tension-free vaginal tape (TVT) technique3.
Mid-urethral slings (MUS) now represent a gold standard in the treatment
of female stress urinary incontinence (SUI) 4. Second
generation inside-out trans-obturator slings (TVT-O) or the later
outside-in trans-obturator (TOT) slings have proven to be as effective
as retropubic TVT with fewer major complications 5. A
third generation of the MUS inserted through a single vaginal incision
(SIS) has become a means to overcome significant post-operative groin
pain. Novel types of SIS with a more reliable and adjustable anchoring
mechanism can assure adequate long-lasting attachment to the obturator
membrane (OM)4.
U.S. Food and Drug Administration (FDA) notifications regarding
vaginally placed meshes have, nonetheless, definitely affected SUI
surgical treatment, and studies are now directed at what type of MUS is
superior to traditional procedures 6. Recent
literature reiterates well established MUS safety and effectiveness,
nevertheless, data regarding SIS still needs additional evidence,
especially concerning the long term7. Although some
modern “third generation” SIS (MiniArc, Ajust), exhibited similar
efficiency when compared to standard MUS, these commonly used products
are no longer on the market 8. Our research group
previously reported one year results of a randomized controlled trial
(RCT) comparing the innovative fixation SIS (Ophira, Promedon) with the
inside-out TOT (Gynecare TVT Obturator System, Ethicon). In short term
follow-up, we determined that an Ophira SIS is non-inferior to Gynecare
TOT with respect to efficacy and, moreover, with significantly less
groin pain during the early postoperative period. Both methods were also
safe and effective in terms of postoperative urgency and life quality
improvement 9. Recently published first long term
results evaluating Ophira SIS efficacy are also promising, although
randomized comparison with standard MUS is still lacking10, 11.
In this study, our goal was to evaluate efficacy and safety of the
Ophira SIS in comparison with the inside-out TOT during a long term
follow-up. Primary RCT outcomes were defined via SUI objective and
subjective cure rate evaluations four years following MUS surgery. Early
and late operative complications, need for recurrent surgery, quality of
life, and urgency incontinence occurrence were selected as secondary
study endpoints.