Transobturator Versus Minisling for Urinary Incontinence: A Randomized Controlled Trial.

IMPORTANCE

The comparison between single-incision slings (SISs) and midurethral slings has been documented in the literature, but results vary according to the SIS device.

OBJECTIVES

The purpose of this study is to assess whether SIS (Solyx) is noninferior to transobturator (TOT) (Obtryx) sling for treating women with confirmed stress-predominant urinary incontinence.

STUDY

DESIGN

A prospective, parallel, nonblinded, multicenter, noninferiority, randomized controlled study with 114 patients were randomized and followed 6 and 12 months after surgery. Interventions were midurethral TOT sling (Obtryx-halo; n = 58) or SIS (Solyx; n = 56). The primary outcome was improvement in the Patient Global Impression of Improvement (PGI-I). Secondary outcomes were the Kings Health Questionnaire (KHQ) instruments after treatment, subjective improvement, and surgical outcomes.

RESULTS

Both groups were homogeneous ( P = NS) regarding sociodemographic and clinical variables. There was improvement in the PGI-I after 6 ( P = 0.001) and 12 months ( P = 0.001) of treatment for women who underwent TOT sling. After 6 months, KHQ scores improved in the TOT group for the following domains: role limitations ( P = 0.026) and physical limitations ( P = 0.006). After 12 months, the TOT group presented better KHQ scores that were statistically significant from the SIS group in incontinence impact ( P = 0.012), physical limitations ( P = 0.001), and severity measures ( P = 0.017). Moreover, the TOT group presented higher subjective improvement after 6 months ( P = 0.006) than the SIS group. Mesh erosion was higher in the SIS group ( P = 0.006). Reoperations were not statistically different between groups.

CONCLUSION

There were higher scores in the PGI-I score and higher subjective improvement for the TOT sling after 6 and 12 months of treatment when compared with the SIS group.