The Mid-Urethral Tapes

Abstract

The tension-free vaginal tape (TVT) Gynecare was first described in 1996 by Ulmsten (1) as a minimally invasive procedure to treat female stress urinary incontinence (SUI). This technique quickly gained a major place in incontinence surgery in Europe and is now being used more and more in North America. Prior to TVT, the gold standard technique to treat SUI was the Burch procedure. Several randomized controlled trials have compared the efficacy and safety of TVT and the Burch procedure. These studies demonstrated that TVT had a lower morbidity and an equal or superior efficacy (on midterm follow-up), justifying the widespread use of this technique (2). The long-term results (5-year outcome) of the procedure are also known (82% to 85% of patients are cured), and they justify the use of this technique (3,4). However, there are concerns regarding its operative safety. A Finnish series (5) of 1455 women treated for SUI demonstrated few vascular injuries (venous lacerations were the most frequent injury reported),whereas Zilbert and Farrell (6) reported a case of right external iliac artery injury. In addition, two deaths due to serious vascular injuries have been reported to the manufacturers (7). Three bowel perforations have also been reported (8). Postoperative voiding difficulties such as transient urine retention are present in 8% to 17%, and urgency in 5% to 15%. Most of these complications seem to be related to the penetration of the retropubic space. Keeping the principle of a minimally invasive procedure to reinforce the structures supporting the urethra, E. Delorme introduced a procedure that would avoid these complications. In 2001, the transobturator procedure was described, in which the tape is inserted through the obturator foramen from outside to inside (in extenso from the thigh folds to underneath the urethra) (9). Even though the transobturator out-in TVT technique is claimed to be a safe procedure, it may cause urethra and bladder injuries (Figure 10.1). In 2003, De Leval (10) described a novel surgical technique that allows the passage of a tape through the obturator foramens, from inside to outside, with the use of newly designed surgical instruments. This technique avoids damage to the urethra and bladder and, for this reason, makes cystoscopy unnecessary. However, the long-term safety of this type of tape is not known, particularly in relation to changes in the synthetic material and changes in bladder and urethral functioning caused by the tape, such as voiding disorders and bladder overactivity.