Randomization and treatment
Before surgery, all eligible patients completed a short International
Consultation on Incontinence Questionnaire (ICIQ-SF) to measure the
impact of patient’s symptoms on quality of life, where ratings ranged
from 0 (no reduction in life quality) to 21 points 2.
Patients were randomized by envelope technique at the time of surgery to
either a TOT or SIS anti-incontinence procedure. For the TOT procedure,
the inside-out Gynecare TVT Obturator System (Ethicon) was used. The SIS
procedure was performed with an Ophira (Promedon) surgical kit. Patients
in both TOT and SIS study groups were treated with standardized surgical
techniques in accordance with manufacturer instructions12. All TOT surgeries were performed by one senior
surgeon with the experience of more than 200 previous surgeries. All SIS
surgeries were undertaken by another specialist with practice of more
than 200 previous MUS surgeries including at least 30 SIS insertions.
Every procedure was carried out under general anesthesia. The urinary
Foley catheter was removed six hours after surgery, and patients were
discharged the next day. No planned concomitant surgery or routine
intraoperative cystoscopy were performed.