Defining success after surgical treatment of stress urinary incontinence

Abstract

BackgroundA consensus standardized definition of success after stress urinary incontinence surgical treatment is lacking, which precludes comparisons between studies and affects patient counseling. ObjectivesTo identify optimal patient-centric definition(s) of success after stress urinary incontinence surgical treatment and to compare the identified “more accurate” treatment success definitions with a commonly used composite definition of success (ie, no reported urine leakage, negative cough stress test result, and no retreatment). Study DesignWe evaluated 51 distinct treatment success definitions for participants enrolled in a previously conducted randomized trial of stress urinary incontinence treatments concomitantly performed with sacrocolpopexy (NCT00934999). For each treatment success definition, we calculated the mean (SD) of participant-assessed symptom improvement and participant-assessed surgical success scores with an 11-point Likert scale among those achieving success and failure. The “more accurate” treatment success definition(s) were identified by measuring the magnitude of the mean difference of participant assessments with Hedges g values. The treatment success definitions with the highest Hedges g values were considered “more accurate” treatment success definitions and were then compared with the composite definition of success. ResultsThe percentage of participants who had treatment success (6.4% to 97.3%) and Hedges g values (–4.85 to 1.25) varied greatly according to each treatment success definition. An International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score of 5 or less, Urogenital Distress Inventory-6 score of 33.3 or less, and a no/mild stress urinary incontinence response on Urogenital Distress Inventory-6 question 3 had the highest Hedges g values and were considered the top 3 “more accurate” treatment success definitions. Paradoxically, treatment success definitions that required a negative cough stress test result or no persistent urinary leakage greatly reduced the ability to differentiate participant-assessed symptom improvement or surgical success. When the “more accurate” treatment success definitions were compared with the composite definition, patients with failed treatment according to the composite definition had lower Urinary Impact Questionnaire-7 scores, and a higher proportion of complete/somewhat satisfaction and very good/perfect bladder condition survey responses. Additionally, the composite definition had considerably fewer favorable outcomes for participants than did the top 3 “more accurate” treatment success definitions. ConclusionsSuccessful outcomes of stress urinary incontinence surgical treatments for women undergoing concurrent sacrocolpopexy varied greatly depending on the definition used; however, stringent definitions (requiring complete dryness) and objective testing (negative cough stress test result) had decreased, rather than increased, participant-assessed symptom improvement and surgical success scores. The “more accurate” treatment success definitions better differentiated participant-assessed symptom improvement and surgical success than the composite definition. The composite definition disproportionally misidentified participants who reported minor symptoms or complete/somewhat satisfaction with their outcome as having treatment failures and yielded a considerably lower proportion of women who reported favorable outcomes than did the top 3 “more accurate” treatment success definitions.