In a prospective, parallel cohort, a multi-center study across 21 sites, surgeons were assigned to perform either SIS Solyx or TMUS Obtryx II slings, based on their experiences. Women with predominant SUI, positive cough stress test (CST), and a PVR <150 ml were eligible for enrollment. Exclusion criteria included patients with prior SUI surgery or prolapse surgery with a mesh complication. Concomitant procedures were allowed at the time of sling placement. Primary outcomes were measured at 36 months based on treatment success—defined by a composite of objective measure (negative CST) and any subjective self-reported improvement in SUI using the Patient Global Impression of Improvement (PGI-I), and secondary outcomes included the presence of adverse events, subjective improvement, and patient-reported outcomes.
140 women were in the TMUS group, and 141 women were in the SIS group. After stratification, there were no differences in terms of age, BMI, race, smoking status, history of diabetes, use of estrogen, prior hysterectomy, menopausal status, history of prior incontinence procedure, or concomitant procedures. At 36 months, treatment success was 88.9% in the TMUS group and 90.4% in the SIS group (p = 0.93). Adverse effect rates were 0.7% in both groups. Mesh-related complications were similar across groups; mesh exposure occurred in 4.3% in the TMUS group and 2.8% in the SIS group (p =0.54), and mesh erosion occurred in 0.7% of the TMUS group and 0% of the SIS group (p =0.50). Dyspareunia (0% in the TMUS group vs 0.7% in the SIS group, p = 1.00), pelvic pain (0% in the TMUS group vs 0.7% in the SIS group, p = 1.00), and urinary retention (4.3% in the TMUS group vs 2.8% in the SIS group, p = 0.54) were comparable across groups.
Based on their three-year results and analyses, the authors concluded that SIS is non-inferior to TMUS for the subjective and objective cure of SUI and serious adverse effects following surgery.
Presented by Amanda White, The University of Texas Dell Medical School
Written by: Judy Choi, MD, Assistant Professor, Department of Urology, University of California, Irvine @judymchoi at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2019, February 26 - March 2, 2019, Miami, Florida