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.