Introduction and Objectives: Suburethral synthetic sling procedures have become widely used as surgical treatment for female urinary stress incontinence. However synthetic slings are expensive. Since 2002, we have used in a non- randomized fashion, Composix-based slings, tension-free vaginal tapes TVT and transobturator tapes TVT-O. The Composix sling was cut from a large sheet used for ventral hernia repair and resterilized. The Composix sling was fitted with 0 Maxon resorbable sutures on each side and positionned suburethrally with a Raz needle introduced though a small suprapubic incision. The goals of this prospective study are to compare the success rate, the durability, the complications and the cost of the three different approaches.
Methods: Among the 103 women suffering from stress incontinence, 60 were assigned to Composix, 28 to TVT, and 15 to TVT-O. Only patients presenting a complete set of data were included int the analysis. Preoperative workups included medical history, clinical examination, a 24-h pad test, FPSUND (symptom score), satisfaction and impact incontinence quality of life (I-QOL) questionnaires. Objective changes in SUI were the primary end point; whereas other outcome variables such as symptoms, quality of life questionnaires and satisfaction scale were our secondary end points. Clinical check ups were conducted at 3 month, each 6 months for 2 years and then annually up to 5 years. The objective result was considered succesfull when the absolute value of incontinence after treatment was ≤ 2 g per 24 hours.
Results: The median follow up of the cohort was 24 months. The median I-QOL scores for the Composix, TVT and TVT-O prior to surgery were 57, 55, 49 respectively, and 106, 106, 109 at 24 months. Similarly, the FPSUND scores were initially 12, 11, 12 and 4, 1, 2 at follow-up, whereas the 11 point-scale satisfaction score improved from 2 to 9 for all groups. The median pad weight was 26g, 66g and 20 g prior to surgery; at 24 months all patients who had not failed int the first 6 months were dry. In the Composix cohort, 1 patient had persistent SUI and 8 required a second intervention, either to loosen tension or to treat a sling erosion. Two patients developped de novo urgency, while 10 patients noticed a partial or complete improvement of their previous urgency. There were 13 minor complications, such as wound or bladder infections. Trauma to the lower urinary tract and complete urinary retention occured in 2 patients each. In the TVT group, 2 bladder perforations occured during surgery. Reintervention was done in another 2 patients. One patient developped de novo urgency and one patient had a recurrence on SUI. No de novo urgency occurred in the TVT-O group. Nevertheless, two patients failed and another required reintervention. One patient had a vaginal laceration recognized and repaired during surgery. No patients in either group suffered any long-term sequellae of their intra- or post-operative complications.
Conclusions: This study did not detect a significant difference between the Composix, TVT and TVT-O slings for the cure of female stress incontinence at a mean follow-up of 24 months. The effect of the all procedures on cure of incontinence and improvement in quality of life is maintained over at least 2 years. The Composix sling was significantly cheaper but the product is no longer available.