Efficacy of the suburethral transobturator Kim system® for female urinary incontinence 10 years after implantation

Padilla-Fernández B1, Núñez-Otero J J2, Salvatierra-Pérez C3, Álvarez-Ossorio Rodal A4, Perán-Teruel M5, Hernández-Hernández D1, García-García M Á2, García-Cenador M B4, Lorenzo-Gómez M F2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 284
Female Incontinence
Scientific Podium Short Oral Session 16
Thursday 30th August 2018
10:05 - 10:12
Hall C
Stress Urinary Incontinence Female Surgery
1. Department of Urology, Hospital Universitario de Canarias, Tenerife, Spain, 2. Department of Urology, Complejo Hospitalario Universitario de Salamanca, Salamanca, Spain, 3. Department of Urology, Hospital Universitario San Pedro, Logroño, Spain, 4. Department of Surgery, University of Salamanca, Salamanca, Spain, 5. Department of Urology, Hospital Arnau de Vilanova, Valencia, Spain
Presenter
B

Bárbara Padilla-Fernández

Links

Abstract

Hypothesis / aims of study
After the introduction of the transvaginal midurethral synthetic sling  in 1996 by Ulmstem, and the description of the transobturator route by Delorme in 2001, the surgical correction of stress urinary incontinence was simplified allowing a minimally invasive approach, being nowadays considered the gold standard for the primary treatment of uncomplicated stress urinary incontinence (UI) without pelvic organ prolapse. However, recent reports of complications with the use of vaginal meshes raise the importance of using biocompatible materials which allow constructive remodelling of host tissues (1), maintaining good continence results.
The aim of this study is to know urinary continence long term results in women who underwent stress UI correction with the transobturator midurethral sling KIM system® (Knotless Incontinence Mesh) with overlock edges.
Study design, materials and methods
A prospective study was conducted in 744 women who underwent short-stay surgery with the midurethral sling KIM system® for SUI between April 2007 and December 2016.
We distinguish two groups: 
* Group A (GA, n=694): continent patients after surgery;
* Group B (GB, n=50): incontinent patients after surgery. 
Age, secondary diagnoses, physical examination and complementary explorations, ICIQ-SF questionnaire results at 48h, 3 months and yearly thereafter. 
Descriptive statistics, ANOVA analysis, Student’s T test, Fisher’s exact test are used; p<0.05 is considered significant.
Results
Continence was achieved in 93.27% patients. Persistent UI or de novo urgency UI were found in 6.73%. Average age was higher in group B (67. 8 years) than in group A (59.38 years). 
Higher evolution time of UI was observed in group B (1976 days) than in group A (1396 days). 
Patients had a higher number of eutocic deliveries in group A (1.82) than those in group B (0.86). 
The percentage of patients with ASA-I score was higher in group A (41.06%), and the percentage of patients with ASA-III score was higher in group B (46%), representing a better performance status of patients in group A.
No differences between groups were found in: body mass index (GA 28.91, GB 26.92), post-treatment follow-up time (GA: 6.15 years, GB 7.01), food or drug allergies, dystocic deliveries, concomitant treatments which may have an impact on bladder function, smoking, diabete mellitus, ASA-II score. 
100% of continence is maintained in the follow-up visits until the fourth year in which it descends to 98%. At 10 years follow-up, 97% of the patients are 100% continent.
Interpretation of results
Recognised risk factors for implanted mesh materials are the product design (e.g., physical characteristics of the mesh, size of the pore as a predisposing factor to infection – in particular with a pore size less than 75 microns), and the characteristics of the material (biocompatibility, long term stability, flexibility, elasticity, etc.) (2).
The knotless KIM System® midurethral sling with overlock edges achieves good continence results. Based on our results, younger patients with less comorbidities and a shorter incontinence evolution time have better results. Given that age is a non-modificable variable, it is advisable to perform the anti-incontinence surgery as soon as possible in order to achieve better results. A finding that we believe may be of the greatest importance is that total continence is maintained 10 years after surgery in 97% of women, which shows the efficacy, safety and reliability of the implanted material.
Concluding message
The midurethral transobturator sling Kim system® achieves urinary continence results higher than 90%, with 2% recurrence at 4 years and 3% at 10 years. The success of the technique is related to age, incontinence evolution time prior to surgery and patient’s general health status.
References
  1. Gigliobianco G, Regueros SR, Osman NI, Bissoli J, Bullock AJ, Chapple CR, MacNeil S. Biomaterials for pelvic floor reconstructive surgery: how can we do better? Biomed Res Int. 2015;2015:968087. doi: 10.1155/2015/968087.
  2. Chapple CR, Cruz F, Deffieux X, Milani AL, Arlandis S, Artibani W, et al. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017 Sep;72(3):424-431. doi: 10.1016/j.eururo.2017.03.048.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee IRB Complejo Hospitalario Universitario de Salamanca Helsinki Yes Informed Consent Yes