Summary objectives: The aim of this study is to describe the surgical technique, and assess the complications and middle-term results of the Contasure Needleless (Neomedic International), a single incision TOT sling for the surgical treatment of stress urinary incontinence. The main concept of this device is that it is not a mini-sling, it has 138% more surface area. We are analyzing the results of a minimally invasive solution that is a TOT like sling with the same known benefits of a TOT and the advantages of a single incision technique. The surface area to support the urethra of the Needleless is very similar to the surface area of the TOT. (16% less surface area of tissue ingrowths) It is 100% macroporous polypropylene without any additional material.
Methods: 120 patients were evaluated retrospectively. They were all treated of SUI with the Contasure Needleless.Female patients were evaluated under clinical study protocol consisting in cough test, urodynamic and Quality Of Life questionnaire, before and after the procedure.
Inclusion criteria: patients with genuine SUI and patients with SUI plus concomitant procedures as prolapse.
Exclusion criteria: patients with ISD and or neurogenic incontinence. Anesthesia used: general (30%) or epidural (70%), patients with associated pathology.
Procedure: The 114 mm long and tension-free mesh was placed beneath the midurethra. The central part is 12 mm wide. The sling can be repositioned during surgery due to the 22 mm wide T-Pocket Positioning System located at the 2 edges. These pockets fixed the sling to the surrounding tissue in order to have the proper tissue in growth and anchoring. A 20mm sub urethral incision was made to dissect the paraurethral spaces only up to the ischiopubic ramus. A surgical forceps with the T-pocket folded was inserted into the dissected spaces and penetrates at the contra lateral side, like the standard transobturator technique. The forceps was introduced until the fascia of the Internal Obturator muscle was perforated. Then the forceps is opened to extend the pocket inside the muscle fibers for fixation.
Results: 120 patients with a mean age of 55 years (from 36 to 79) and a mean number of deliveries of 3 (0-7). Follow-up period: 24 months. SUCCESS RATE: 100 patients (84%) Improved rate: 10 patients (8%) Failure rate: 10 (8%) Mean operating time of sling procedure alone: 9 minutes (4-12).
Complications: 3 patients had mesh extrusion solved with estrogens and 2 patients required short term catheterization due to voiding difficulties and no patients had inguinal pain.
Conclusions: The results of the study suggest that the Contasure Needleless 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.