Mini Sling (Ophira) versus Pubovaginal Sling for Treatment of Stress Urinary Incontinence: A Medium-term Follow-up.

To compare two different procedures, mid-urethral mini sling (Ophira) and autologous rectus fascia sling, according to their medium-term subjective and objective outcome and satisfaction rates in the treatment of stress urinary incontinence in women. One hundred women with the main complaint of stress urinary incontinence were randomized to be treated with either mini sling (Ophira) or autologous rectus facia pubovaginal sling. Preoperative evaluation consisted of: physical examination, blood biochemistry urine analysis and culture, urinary tract ultrasound scan, conventional multi-channel urodynamic study, cystourethroscopy, cough induced stress test and Incontinence Impact Questionnaire (IIQ). The patients were objectively and subjectively re-evaluated at 1, 3, 6 and 12 postoperative months and the last visit and the collected data of more than one year follow-up were compared with preoperative assessments. Seventy two out of one hundred patients were followed for a mean time of 13.8±4.4 months (12-20 months range). Objective cure rate, according to cough-induced stress test was recorded in 88.6% and 89.2% of the mini sling (Ophira) and the rectus facia sling group respectively (P=1.0). Postoperative mean IIQ score decreased to 42.7±11.4 and 50.2±11.1 in the mini sling (Ophira) group versus rectus facia pubovaginal sling (P=0.007). Twenty eight (80%) and 23 (67%) patients in the mini sling (Ophira) and rectus facia pubovaginal sling were satisfied with the operation (P=0.23). There is no significant difference between the mini sling (Ophira) and autologous rectus fascia sling procedure in the treatment of stress urinary incontinence at medium-term follow-up.

RCT Entities:   Population Interventions Outcomes