COMPLICATIONS OF THE SURGICAL TREATMENT OF FEMALE URINARY INCONTINENCE WITH NEEDLELESS ®. RESULTS IN 8 YEARS.

Amela Arevalo A1, Baya Pejenaute G1, Maldonado Jimenez A1, Miserachs Sala M1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 619
E-Poster 3
Scientific Open Discussion Session 31
Friday 6th September 2019
13:10 - 13:15 (ePoster Station 7)
Exhibition Hall
Female Stress Urinary Incontinence Grafts: Synthetic Prospective Study Surgery
1.Althaia Manresa (Barcelona)
Presenter
A

Alda Amela Arevalo

Links

Abstract

Hypothesis / aims of study
Needleless® sling consist on a macroporus monofilament polypropiylene mesh of 11,4cm length and 1,4cm wide with a Pocket Positoning System(PPS) the anchorage. The insertion technique consists in a longitudinal 1,5cm incision in the anterior vaginal wall with dissection of the paraurethral spaces up to the ischiopubic ramus. The sling is introduced with a Kelly clamp in the PPS through the dissected spaces and penetrate at 45º from the horizontal plane perforating the fascia of the internal obturator muscle.
In a meta-analysis of 11 trials and 5 studies, the combined mesh erosion rates for retropubic an transoburator sling procedures ranged form 0 to 15 percent. A different study that followed nearly 600 women assigned to either a retropubic or transoburator sling for up to 24 months reported synthetic mesh complicaciotns in approximately 4 percent of women. 
The complications described for the vaginal meshes are mesh exposure, mesh contraction (shrinkage of the mesh), pain (including dyspareunia and associated with contracture), infection, bleeding and bladder perforation, voiding dysfunction or urethral erosion. 
Mesh exposure rates for miduretral slings varies from 0-4,7%. Risk factors for mesh exposure include trocar injury, type of material, diabetes, bleeding, surgical complicaciotns vaginal incision lenght greater than 2cm, and history of prior prolapse, prior bariatric or incontinence surgery. 
Urinary tract infections (UTIs) are reported in up to 32 percent of patients. The use of prophylactic antibiotics reduced the rate of immediate postoperative UTIs to 7.5-17.2%. Vaginal wound infections or pelvic, retropubic abscess formation following midurethral sling procedures occur infrequentily and have not been reported in the literature. 
Most of the voiding disfunction are is transient and self-limited. Data from several large, well-designed randomized trilas have shown that dthe rate of voiding dysfunction requiring urethrolysis is less than 3 percent.
Erosion of syntethic mesh into the urethra has been estimated to occur in less than 1 percent of cases. 
Preliminary studies  suggested that Needleless sling, a single incision technique for the treatment of female SUI, may have better clinical efficacy and less intra and postoperative complications than TVT/TOT surgery, as we avoid the transobturator/retropubic route, but keeping the Tension Free concept. 
The aim of this study is to evaluate long term follow up safety and immediate and long term complications occured in patients with a tension-free procedure (CONTASURE NEEDLELESS® ) for the surgical treatment of stress urinary incontinence (SUI).
Study design, materials and methods
Prospective study was carried out in 344 patients with SUI since 2007. Clinical history, quality of life questionnaire, ICI-Q and Sandvik Test and urethral mobilization study was done. Subjects with ISD and recurrent urinary incontinence were excluded. 
We evaluate surgery characteristics (operation time, anesthesia type)and intra and postsurgery complications.
Control of complications where analyzed annually with a clinical examination that includes global satisfaction, ICIQ and genital exploration. We collected data from patients with complete follow-up over 8 years.
Results
We present complications on 177 patients who have reached a follow up of 8 years. 81% of the surgeries were done under local anesthesia and sedation, 17% with locoregional and 2 with general anesthesia (because other surgery was performed). Mean operating time for the mesh placement was 7 min. 
Intraoperative complications were reported in 44 patients (24.75%), all of them involving bleeding (33% lower than 50ml 64% over 50-200ml). None transfusion required. No bladder perforation occurred. 
Immediate postoperative complications were described in 16 patients (8.9%): 3 acute urinary retention (that was solved with catheterization), 1 severe pain, 4 urinary infections and 4 hematoma (sovled with consevative treatment).
No mesh exposures occurred after one year. In one case urinary retention with obstruction appeared and    sectioning of the mesh was required. 6 patients had de novo urge incontinence (3,39%). 
After 8 years: 5 cases of mesh small exposures (2.82%) were found, all of them was solved with local oestrogens. No other long term complications were reported..
Interpretation of results
The anatomical considerations and methodology of this unique procedure (avoiding  transobturator and retropubic route) should minimize patient morbidity. Low rates of complications occur and most of them were mild. The results obtained are similar to the data described in the literature.
Concluding message
Single-incision Needleless sling is considered to be a convenient, safe and effective minimally invasive surgery for SUI.
References
  1. Trabuco, E. et al. Transvaginal synthetic mesh: complictions and risk factors. Uptodate, February 2019
  2. Fu et al. The clinical efficacy of needleless sling technique and TOT in the treatment of female stress urinary incontinence: a prospective randomized controlled trial. Int J Clin Exp Med 2017;10(4):7084-7090
  3. Jelovsek, E et al. Surgical management of stress urinary incontinence in women: Choosing a primary surgical procedure. Uptodat, February 2019
Disclosures
Funding Female Stress Urinary Incontinence (SUI) Clinical Trial No Subjects Human Ethics Committee ALTHAiA HOSPITAL ETHICS COMMITTEE Helsinki Yes Informed Consent Yes
20/04/2024 09:40:18