Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients.

OBJECTIVE

A prospective study was undertaken to examine the incidence of surgical complications and medium-term outcomes of tension-free vaginal tape (TVT) surgery in a large, heterogeneous group of stress-incontinent women.

METHODS

Surgery was tailored according to preoperative clinical and urodynamic findings: stress-incontinent women underwent TVT surgery, whereas those with concomitant urogenital prolapse underwent combined TVT and prolapse repair. Post-operatively the patients were scheduled for evaluation at 1, 3, 6, and 12 months, and annually thereafter. All underwent urodynamics at 3 months post-operatively.

RESULTS

Three hundred and thirteen consecutive patients were prospectively studied. The mean follow-up period was 21.4 +/- 13.5 months. Sixteen (5.1%) cases of intravesical passage of the prolene tape occurred in our series, two of which were diagnosed at 3 and 15 months post-operatively. Eight (2.5%) patients had post-operative voiding difficulties, necessitating catheterization for more than 7 days. However, transvaginal excision of the tape was required in one case only. Vaginal erosion of the tape was diagnosed in four (1.3%) patients, all of whom were successfully treated by local excision of the eroded tape. Outcome analysis was restricted to 241 consecutive patients with at least 12 months of follow-up. Subjectively, 16 (6.6%) patients had persistent mild stress urinary incontinence, although urodynamics revealed asymptomatic sphincteric incontinence in 17 (7%) other patients. De-novo urge incontinence developed post-operatively in 20 (8.3%) patients.

CONCLUSIONS

The TVT procedure is associated with good medium-term cure rates, however, it is not free of troublesome complications and the patients should be informed accordingly. Only well-trained surgeons, familiar with pelvic anatomy, surgical alternatives, and endoscopic techniques should perform the operation.