Presentation Authors: Amanda White, Austin, TX, Karyn Eilber*, Jennifer Anger, Los Angeles, CA, Bruce Kahn, San Diego, CA, Joseph Schaffer, Dallas, TX
Introduction: Compare patient-reported outcomes(PROs) after single incision sling(SIS) and transobturator mid-urethral sling(TMUS).
Methods: This is a planned secondary analysis of a prospective study comparing SIS to TMUS. 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(UI) using Patient Global Impression of Improvement (PGI-I) at 36 months. We 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.
Results: Baseline characteristics were balanced after propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age(49.1Â±11.6 vs 48.9Â±11.7, P=0.4), body mass index (29.6Â±7.3 vs 29.7Â±6.3, P=0.9), and concomitant surgery(66.9% vs 59%, P=0.2). 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 (Table 1).
Conclusions: 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. Patients have a more positive impression of change in stress UI symptoms at each follow-up visit, indicating generic QoL improvement.
Source of Funding: 522 Order, Boston Scientific