NEW YORK (Reuters Health) – Long-term follow-up results from a small Turkish trial in women with stress urinary incontinence suggest that a tissue fixation system mini-sling (TFS) has a higher cure rate and fewer complications than transobturator tape (TOT).
The original single-blind study involved 80 women who were randomized to TFS (TFS Surgical, Adelaide, South Australia, Australia) or TOT (I-STOP, CL Medical, France) and followed for three years. The current study extends the findings to more than five years.
Dr. Ahmet Akin Sivaslioglu of the Ankara Ataturk Training and Research Hospital and colleagues published the update online May 14 in The Journal of Urology.
They write that when they began the original study in 2005, “to our knowledge there were no other data available for mini-slings.” However, it appeared that the cure rate with TFS was similar to that with tension-free vaginal tape (TVT) and TOT slings.
The median follow-up is now 64 months, and the team has data on 36 women in each group.
The objective cure rates at three and five years in the TFS group were 90% and 83%, respectively, compared to 84% and 75% in the TOT group.
The difference in objective cure rates was statistically significant in favor of the TFS but the relative difference in cure rates by five years was not significant. Failure rates were 11% in the TFS group and 22% in the TOT group.
Quality-of-life scores improved after both operations.
Dr. Sivaslioglu and his colleagues believe the superior results with TFS “are mainly due to the unique design of the system, the strong grip of the anchors… and the precise one-way tensioning system.”
Dr. Sivaslioglu told Reuters Health by email, however, that “more randomized studies with larger samples are needed to confirm these findings.”
Other shorter studies have suggested that overall, TVT may be the better option (see Reuters Health report of Feb 14, 2012).
J Urol 2012.