Midterm prospective evaluation of TVT-Secur reveals high failure rate

Background: TVT-Secur has been described as a new minimally invasive sling for women's stress urinary incontinence (SUI) management, showing promising results in short-term studies.

Objective: Our goal was to evaluate the outcome of this procedure after a midterm follow-up.

Design, setting, and participants: A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP).

Intervention: Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon.

Measurements: Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I score < or = 2; as improved in case of reduction of SUI symptoms >50% and PGI-I score < or = 3; and as failure otherwise.

Results and limitations: Mean postoperative follow-up was 30.2 +/- 9.8 mo (range: 11-40 mo). Short-term evaluation showed a 93.5% success rate, but, at last follow-up, only 18 (40%) patients were cured, while 8 (18%) were improved, and 19 (42%) failed. Twelve patients underwent implantation of TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group.

Conclusions: Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women.