female stress urinary incontinence treatments with adjustability single incision sling (Altis), middle-term results

gentile b1, MIRABILE G1, giulianelli r1, albanesi l1, tariciotti p1, lombardo r1, aloisi p1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 816
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Incontinence Stress Urinary Incontinence Surgery
1.NUOVA VILLA CLAUDIA
Links

Abstract

Hypothesis / aims of study
Stress urinary incontinence (SUI), the involuntary urine leakage due to failure of the urethral closure mechanism, is  a common problem worldwide,  with substantial human suffering and socioeconomic costs.  Approximately 167 million male and female patients are predicted to suffer from SUI in 2018, worldwide. A wide range of surgical interventions are available for the treatment of SUI. success rate of surgical procedures in SUI patients with intrinsic sphincter deficiency (ISD) is low. Despite a lack of standardised international definition, ISD needs to be clearly diagnosed in order to be correctly treated.  Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.
The aim of this study is to describe the surgical technique, and middle-term results of the adjustability single incision TOT sling (Altis) for the surgical treatment of stress urinary incontinence.  on patients with SUI and normotonic urethra and ISD.
Study design, materials and methods
METHODS:
the patient-reported cure rate, objective cure rate, operative time, postoperative pain, lower urinary tract injuries, groin pain, postoperative voiding difficulties, de novo urgency, vaginal tape erosion, and other related data on both surgical methods were evaluated.
INCLUSION CRITERIA:
patients with genuine SUI, ISD   and patients with SUI plus concomitant procedures as prolapse. Although there is no international consensus definition, we can consider that the ISD is a composite concept combining urodynamic data.  Although the clinical parameters for ISD are loosely defined as a Valsalva leak-point pressure <60 cmH(2)O or a maximal urethral closure pressure <20 cmH(2)O, consensus is lacking.  one or more clinical information (no urethral mobility, negative urethral support test, failure of a first surgery, leakage during abdominal straining, high stress incontinence scores). 
EXCLUSION CRITERIA:
patients with neurogenic incontinence. 
PROCEDURE:
The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)."
There are four components that make up the Altis Single Incision Sling System: the introducers, the sling, the anchors and the tensioning suture. The anchors are placement into the obturator membrane with the introducers as a set for the inside-out approach. The sling is 7.75cm and spans from obturator to obturator. Extending from the sides of the sling is a size 1 PP monofilament suture that is attached to the sling body. 
The suture extending from the sling and through the dynamic anchor or the movable anchor is designed for two way adjustability. The dynamic anchors holding force and suture design prevents sling movement during the tissue in-growth period. This also eliminates the need for a locking mechanism. Following the procedure, the excess suture is cut and discarded.
Results
55 patients with a mean age of 55 years (from 36 to 79)  Follow-up period: 24 months. SUCCESS RATE: (89%) Improved rate: 4%Failure rate: 3%  Mean operating time of sling procedure alone: 11 minutes. there were no differences in results in follow-up at 1, 3, 6 months in patients with SUI and ISD. However the continence decreased to one year (83%) , not keeping in time in patients with ISD.
The women no had  short‐term pain or discomfort after a single‐incision sling alone
COMPLICATIONS:
no voiding difficulties and no dysuria no mesh extrusion
Interpretation of results
A brief economic commentary (BEC) identified two studies which reported no difference in clinical outcomes between single-incision slings and transobturator mid-urethral slings, but single-incision slings may be more cost-effective than transobturator mid-urethral slings based on one-year follow-up.  Additional adequately powered and high-quality trials with longer-term follow-up are required.  In our experience SIMS-Altis is safe and effective in the treatment of female stress urinary incontinence, with short operation time and no need hospitalitazion. The technique is simple but requires at the beginning a good knowledge of the anchoring system.
Concluding message
The results of the study suggest that the adjustability single incision sling (Altis) can be considered a minimally invasive TOT with no-needles and maintaining the same cure rate than our TOT cases at 2 years follow up, but in pts with ISD the results may not last over time
Disclosures
Funding none Clinical Trial No Subjects Human Ethics not Req'd it's a usual surgery Helsinki Yes Informed Consent Yes