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.