Outcomes
Follow-up visits four years after surgery were all done by an independent clinician and included evaluations of objective and subjective cure as primary study outcomes. Objective cure was defined as absence of urinary leakage in standardized CST. Subjective cure was assessed with a Patient Global Impression of Improvement (PGI-I) form utilizing a seven-point satisfaction scale (1-7) 13. Cure was defined as a response of 1 “very much improved”, 2 “much improved”, or 3 “improved”. Secondary outcomes included changes in quality of life questionnaire scores (ICIQ-SF) and postoperative de-novo urgency occurrence measured via a Patient Perception of Intensity of Urgency Scale (PPIUS) ranging from 0 (no urgency) to 4 (urge incontinence) 14.
All major intraoperative and postoperative complications were recorded according to joint ICS/IUGA classification related to the insertion of a prosthesis distinguishing urinary tract compromise or postoperative urine retention, infection, abscess, rectum or bowel perforation, skin or musculoskeletal damage, and heavy bleeding including hematoma or systemic patient compromise 15.
Tape exposure was defined as mesh visualized through separated epithelium, whereas tape extrusion as gradual passage of mesh out of the body tissue. Furthermore, all surgical re-interventions were reported differentiating procedures performed because of primary surgery failure and procedures related to mesh or surgery complications. All definitions are in keeping with the recommendations of IUGA and ICS16.