An adjustable single-incision sling for treating urinary incontinence was less painful postoperatively than the standard synthetic midurethral sling placed via the transobturator route (TVT-O), according to recently published results of a randomized trial.
The study, conducted in The Netherlands, was an early assessment of a new transobturator device called Ajust, which does not require penetration of the external obturator and adductor muscles of the upper leg for proper placement. The new sling is being compared with the standard TVT-O, in the hopes of reducing postoperative pain while maintaining results.
- A new adjustable single-incision sling device for treating urinary incontinence proved to have lower postoperative pain scores when compared with the standard TVT-O, a recent study found.
The single-blinded, controlled study allocated 156 women with stress urinary incontinence to receive either an adjustable single incision using Ajust or TVT-O. Those who received the Ajust sling reported lower early postoperative pain scores using a visual analog scale, according the published results in Obstetrics & Gynecology.
In the first week postoperatively, the mean pain score was significantly lower at all time points for women in the adjustable single-incision sling group compared with the TVT-O group. However, there was no statistical difference in the use of pain medication, the authors reported.
The study also compared cure rates for both procedures, finding them to be comparable (90.8% for the adjustable single-incision sling vs 88.6% for the transobturator sling). There were no differences in complication rates for either device.
Because placing a synthetic midurethral sling using the transobturator approach is associated with more groin pain than the retropubic TVT approach, the new device aims to reduce pain associated with the procedure, according to information filed with the Netherlands Trial Register. The primary benefit of the transobturator approach, compared with the retropubic approach, is that the risk of bladder perforation is minimal.
“The groin pain is most likely due to perforation of the external obturator and adductor muscles of the upper leg,” the trial information explains. “The new transobturator device Ajust does not penetrate these muscles and is therefore in theory less painful as compared to the TVT-O, with the benefit of reducing the risk of bladder perforation as compared to the retropubic TVT.”
The trial looked at data on postoperative pain for up to six weeks after the procedure and involved weekly telephone interviews with patients.