Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial.

OBJECTIVE

To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence (SUI).

METHODS

This single-blinded randomized controlled trial involved 156 women with clinically proven SUI. Women were allocated to receive either an adjustable single-incision or a transobturator sling. The primary outcome was postoperative pain score on a visual analog scale. Secondary outcomes were objective and subjective cure rates at 12 months, symptom bother scores, quality of life, and complications.

RESULTS

The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group. Maximum difference in pain score was reported on the evening of the day of surgery; median pain score was 1.0 (interquartile range 2.0) in the adjustable sling group and 3.0 (interquartile range 4.5) in the transobturator sling group (Mann Whitney U test P<.001). There was no statistical difference in analgesic use. The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8% and 88.6% (P=.760), and the subjective cure rates were 77.2% and 72.9% (P=.577), respectively. No difference in the complication rate was found.

CONCLUSION

An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up.

CLINICAL TRIAL REGISTRATION

Netherlands Trial Register, http://www.trialregister.nl, NTR: 2558.

LEVEL OF EVIDENCE

I.