Hypothesis / aims of study
For the first time we compare the effectiveness and safety of mid-urethral sling (TOT) procedures versus the collagenic threads in women with stress urinary incontinence (SUI), and to evaluate whether this new system represents a viable minimally invasive alternative. The aims of this study were to access the impact in the Quality of life (QoL) as well as to demostrate the anatomic changes obtatined in these two procedures, using transperineal Ultrasound.
Study design, materials and methods
This prospective, non-randomized comparative study included 50 women with clinically
diagnosed SUI. Patients were allocated to mid-urethral sling (n=25) or Collagenic threads system
(n=25). All procedures were performed by experienced surgeons. The primary endpoint
was objective cure at 12 months, defined as absence of leakage during stress testing.
Secondary outcomes included perioperative complications and patient-reported
satisfaction. Statistical analysis was performed using Fisher’s exact test. Effect size was
expressed as absolute risk difference (RD) with 95% confidence interval. Transperineal ultra sound (TPUS), Mindray I9, with a convex probe of 5Hz, was used to evalueted (BND, URA, RVA) and questionnaires (ICIQ-SF, Sandvik, PFDI-20, PISQ-12) were assessed preoperatively and at 12 months. Statistical significance set at p < 0.05. Transobturator slings were performed according to Delorme description(2001) and PDO threads wrere used to reinforce both urtethrpelvic and puboutrethral logaments, pre and retropubic. These procedures were carried out under local anesthesia in outpatient basis.A Foley catheter with a metallic guide inside (bayonet) is used to move the urethral upwards, avoiding urethral and bladder perforations. Besides the tips of the canula are blunt, making the procedure even safer.
Once the urethra and bladder neck are moved upwards, the threads are introduced in the previous made punctures, first in a “X” format and next is an “A” shape creating a backboard support to the urethra, similar to a sling, reinforcing the urethropelvic ligament. Next, the bayonet is removed an prepubic canulas are insert on each vaginal sulcus, finally the reropubic threadds are insered using the same orifices in the vaginal wall. no catheter is left in place.
Interpretation of results
Both techniques demonstrated high efficacy and excellent safety profiles. The wide
confidence interval reflects limited statistical power but remains compatible with a
clinically meaningful benefit. The consistent numerical advantage observed with the
threads group supports further investigation.