TVT Secur™: More and more minimal invasive. Preliminary prospective study on 110 cases

Objectives. - To present a new minimal invasive suburethral tape device derivative of the classic TVT, to describe the technique of laying, to evaluate complications and results to short term. Materials and methods. - Prospective multicentric study of 110 patients presenting a stress urinary incontinence and benefiting from the laying of TVT Secur (TM) without associated operation. The tape is identical to that old-fashioned retropubic and obturator TVT, smaller, laying in "U'' or in "hammock'' without orifice of exit, to avoid complications due to crossed spaces of the other techniques. The device and the technique of laying are described by authors. The originality of the TVT Secur (TM) resides in the mechanism of insertion of the tape to a metallic divice. All patients have been controlled at two months and complications with notably pains (quotation VAS) as well as objective results have been reported. Results. - Pure and isolated stress urinary incontinence for 71 patients, mixed incontinence for 39 and sphincter deficient for 23. Preoperative urgency for 49 patients and dysuria for 10 of them. The method "hammock'' has been used in 85.5% of cases. The type of anaesthesia has been pure local for 69.1% (0 to 98.8% for the different centers) with an average operative time of 8'30''. Under local anaesthesia, the average per operative pain was quoted 2.8/10, and 0.7 at the end of intervention. Peroperative complications have revealed a wound of bladder, a vaginal wound and four bleeding of more than 100 ml. In immediate continuations a total retention yielding to 24 h and 13 postmicturition residual between 100 and 200 ml have been mentioned. At two months, authors have observed the following: de novo urgency in 19.6%, de novo dysuria in 13.2%, one tape exposition, one granuloma, one urinary infection and seven perceptible lateral cords without pain. Thirteen patients have signalled to have had moderated pains on a duration of four to 30 days. Early objective results are globally 70.4% of dry patients (83% for pure isolated SUI, 72.2% for SUI with deficient sphincter, 50% for mixed incontinence). The pure local anaesthesia was recommended by 98% of patients. Conclusion. - The diminution of complications ahead not to be made to the detriment of results, it is necessary to envisage multicentric studies with standardized modi. cations. The indications of this new device will have to be defined. (C) 2008 Elsevier Masson SAS.