AUA 2019: Solyx vs. Obtryx of the Minisling vs Transobturator Sling in SUI Women

Chicago, IL (UroToday.com) This was a planned secondary analysis of a prospective study comparing single-incision sling (SIS) to transobturator mid-urethral slings (TMUS). The primary study aim was to compare efficacy and safety using a noninferiority (NI) design to detect 15% difference in treatment success and 10% difference in safety.

Treatment success was defined by composite objective measure (negative cough stress test) and subjective improvement in stress urinary incontinence (SUI) using Patient Global Impression of Improvement (PGI-I) at 36 months. They collected validated PROs at baseline, 6,12,18,24, and 36 months to quantify UI severity (Incontinence Severity Index (ISI)), symptom bother (Urogenital Distress Inventory(UDI-6)), disease-specific quality of life (QoL) impact (Urinary Impact Questionnaire(UIQ-7)), and generic QoL impact (PGI-I). PROs were analyzed within treatment groups as well as between groups.

Baseline characteristics were balanced after propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age (49.1±11.6 vs 48.9±11.7, P=0.4), body mass index (29.6±7.3 vs 29.7±6.3, P=0.9), and concomitant surgery (66.9% vs 59%, P=0.2). The average length of follow-up was 30 months. Treatment success was 90.1%(91/101) in SIS and 89.3%(92/103) in TMUS among available cases in per protocol analysis. Treatment difference was -1.3%, 90% CI [-9.3%, 6.6%], demonstrating NI at the pre-set margin. In both groups, serious adverse event (AE) rate (mesh-related complications) was 0.7%, and AE rates (dyspareunia, pelvic pain, and urinary retention) were low. Participants had significant improvement in UI severity, disease-specific symptom bother and QoL impact, and improvements persisted through the study. PROs were similar between treatment groups in all assessments at 36 months.

They concluded following SIS and TMUS, patients have significant improvement in PROs including UDI-6, ISI, and UIQ-7 at 36 months, indicating disease-specific QoL improvement. They also found that patients have a more positive impression of change in stress UI symptoms at each follow-up visit, indicating generic QoL improvement.

Presented by: Karyn Eilber, MD, Urology, Cedars Sinai Health System, Beverly Hills, California
Co-authors: Amanda White, Jennifer Anger, Bruce Kahn, Joseph Schaffer

Written by: Bilal Farhan, MD, Clinical Instructor, Female Urology and Voiding Dysfunction, Department of Urology, University of California, Irvine @BilalfarhanMD at the American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois
email news signup