By Joanna Lyford, Senior medwireNews Reporter
A mini-sling that requires a single incision may be a viable alternative to the “gold standard” transobturator midurethral sling for the treatment of stress urinary incontinence, a randomised controlled trial has found.
Although the mini-sling was less effective than the standard approach in terms of objective cure rates, it offered other benefits such as being quicker to perform and causing less postoperative pain.
“The main advantage of the single-incision sling might be the possibility of performing this procedure under local anesthesia with a shorter operation time,” suggest Lucyana Djehdian (Federal University of São Paulo, Brazil) and co-authors writing in Obstetrics & Gynecology.
The trial included 130 women with stress urinary incontinence who were due to undergo surgery at a single centre. They were randomly assigned to receive the Ophira mini-sling or standard transobturator midurethral tape.
The mini-sling consists of a central tape measuring 38x9 mm and two self-anchoring “fishbone” columns, according to the study authors. It is inserted under local anaesthesia with a single vaginal incision and anchored to the obturator internus muscle at the level of the arcus tendineus.
The study’s primary endpoint was the cure rate 1 year after surgery. The objective cure rate, defined as negative cough stress and pad tests, was 68.1% with the mini-sling group and 81.9% with the transobturator sling.
Meanwhile, the subjective cure rate, defined as patients who considered themselves satisfied with treatment, was 81.1% with the mini-sling and 88.5% with the transobturator sling.
Neither of the between-group differences was statistically significant. However, the mini-sling did not demonstrate non-inferiority because the upper limit of the confidence interval was above the prespecified margin of 15%.
Among the secondary endpoints, women in both groups reported a significant improvement in urinary symptoms and in their quality of life following surgery. The improvement in social embarrassment was greater with the transobturator sling than with the mini-sling, however.
Finally, complications were similar in both groups with the exception of thigh pain, which was significantly greater with the transobturator sling (7.1 vs 0%).
The researchers conclude that while “non-inferiority of the mini-sling cannot be assumed”, both methods had few complications and significantly improved the women’s quality of life.
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