Hypothesis / aims of study
The prevalence of urinary incontinence in women aged more than 60 years old was 29.8% , which has drawn attention recently. Single incision sling surgery is the mainstream for surgical intervention of urinary stress incontinence. Studies have shown that postoperative voiding difficulty remains to be troublesome for most of gynecologist, especially the traditional Burch procedure. The modern mesh sling was first introduced in 1995, which was further refined and coined by Ulmsten as the tension free vaginal tape (TVT). This quickly became the new gold standard in many surgeon's opinion as the number of studies and short and medium-term outcome date accumulated and showed positive results. However, voiding difficulty and postoperative neo stress urinary incontinence are still significant issues to this date. Some studies has investigated surgeries for stress urinary incontinence. One study showed women underwent sling surgery using the Solyx had 90% cure rate. Another research revealed Ophira Mini Sling System is an effective method with success rate of 85.3%, for treating SUI . However, there are no systemic trials to compare sling surgery with different kits. Therefore, the aim of this study was to evaluate the three system of sling surgeries and further compared the outcomes in post-operation.
Study design, materials and methods
We recruited patients from single medical center, since July 01, 2015 to June 30, 2018. We randomize patients into three different trial group, sling surgery with Solyx sling (Boston Scientific Corp; Natick, MA, USA), Ophira mini-sling system (Promedon; Cordoba, Argentina) and Contasure-Needleless System (Neomedic International). We included patients with severe stress urinary incontinence. In addition, we excluded patients’ with mixed urinary incontinence, overactive bladder or pad test less than 10 gram.
The primary statistics being monitor are the cure rates in follow up examination after half a year. The secondary statistics are postoperative complications, including De novo overactive bladder (OAB), postoperative leaking and voiding difficulty (VD). The analysis was performed using the ANOVA, and univariate logistic regression. Analyses were performed with the use of SAS statistical software, version 9.2 (SAS Institute). The significant level used was p value<0.05. This study was approved by the Institutional Review Board of the hospital.
Interpretation of results
This study shows that three kit have similar cure rate. However, non-anchor kit system have less complications after six months followed-up. This is the first study that compares the three different kits in sling surgery.
This study also suggests that non-anchor kit system may result in postoperative urine leaking after visit but it would not be the cause for difficulty in voiding. Tissue regeneration plays an important role in this finding. It is mandatory to monitor more population with longer time-frame to get accurate information.
One research established that an appropriate level of post‐implantation acute inflammation is important to precipitate moderate fibrosis  which strengthens the power of mesh.