The comparison of three different surgical kits in patients with severe urinary stress incontinence

Pan H1, Li W2, Chang J2, Huang L1, Pan C3, Pan K3, Ko M4

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 340
E-Poster 2
Scientific Open Discussion ePoster Session 18
Thursday 5th September 2019
13:35 - 13:40 (ePoster Station 5)
Exhibition Hall
Pelvic Organ Prolapse Stress Urinary Incontinence Voiding Dysfunction
1.Shin Kong Hospital; Fu Zen Catholic University, 2.Shin Kong Hospital, 3.University of British Columbia, 4.Ranchland medical centre
Presenter
H

Hans Pan

Links

Poster

Abstract

Hypothesis / aims of study
The prevalence of urinary incontinence in women aged more than 60 years old was 29.8% [1], 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 [2]. 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.
Results
Table 1 demonstrated the demographic data in patients underwent sling surgery with different kits. Based on the cure rate after one-year follow up and patients’ complaints during first visit,  the result suggest that anchor kit system is better than needle-less system. However, VD and de novo OAB are not seen in needle-less system.
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 [3] which strengthens the power of mesh.
Concluding message
The study shows that sling kit with anchor fix is prone to cause VD. Needle-less kit has obvious urine leakage but will subside after 6 months. It is worth noting that these trends are noticible but there is no cause and effect correlation. Sling kit with anchor fix is better suited for patients with stress unrinary incontinence. On the other hand, needle-less kit is better suited for patients with past neural disease such as Parkinson’s disease. To obtain more accurate results, larger sample population size and longer experimental time-frame is required.
Figure 1 Table.1
References
  1. Hsieh, C. H. et al.,Risk factors for urinary incontinence in Taiwanese women aged 60 or over
  2. Lo TS. et al., Evaluation of Clinical Outcome and Risk Factors for Failure of Single-incision Midurethral Short Tape Procedure (Solyx Tape) for Stress Urinary Incontinence
  3. Chapple CR. et al., Application of Tissue Engineering to Pelvic Organ Prolapse and Stress Urinary Incontinence
Disclosures
Funding No Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics Committee Skin Kong Hospital IRB Committee Helsinki Yes Informed Consent Yes