One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.
OBJECTIVE
The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety.


METHODS
We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery.


RESULTS
No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001).


CONCLUSIONS
The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.
Department of Obstetrics and Gynecology, Skåne University Hospital, Lund and Lund University, Sweden, SE-22185 Lund, Sweden.
Maria
M
Andrada Hamer
Per-Göran
PG
Larsson
Pia
P
Teleman
Christina Eten
CE
Bergqvist
Jan
J
Persson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D007902:Length of Stay; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D016037:Single-Blind Method; D053825:Suburethral Slings / Q000009:adverse effects / Q000145:classification*; D013548:Sweden; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000453:epidemiology / Q000601:surgery*