An in-house Composix™-based pubovaginal sling trial for female stress urinary incontinence: Five-year comparative followup to tension-free and transobturator vaginal tapes

Abstract

Introduction: We compared the efficacy of three slings in the longterm treatment of stress urinary incontinence (SUI): tension-free vaginal tape (TVT), vaginal tape-obturator (TVT-O), and an in-house two-layered polypropylene mesh with a submicronic polytetrafluoroethylene (Composix™). Our primary endpoint was the objective measurement of continence (24-hour pad test). Secondarily, we measured the satisfaction and complication rates. Methods: This prospective, non-randomized study included 128 patients with SUI. Preoperative evaluation included medical history, physical exam, 24-hour pad test, Urinary Incontinence Quality of Life Scale (IQOL), FPSUND, and global satisfaction questionnaires. Patients were followed at one month postoperative, biannually for two years, and then annually for a total of five years. Followup visits included a focused questionnaire, physical exam, satisfaction questionnaire, 24-hour pad test, IQOL, and FPSUND questionnaires. Results: Composix, TVT, and TVT-O groups included 60, 34, and 34 patients, respectively. No significant differences were found in baseline characteristics except for the pad test. Length of catheterization was the only immediate operative significant parameter (Composix 4.7 days vs. TVT 1.1 days vs. TVT-O 2.6 days; p=0.03). The entire cohort had significant improvements in their IQOL, FPSUND, and pad test at one and four years (p<0.01). The cohortwide 24-hour pad test average weight was 30.4 g preoperatively vs. 5 g at 12 months (p<0.00001) (Composix 37 to 5 g, TVT 83 to 4 g, and TVT-O 55 to 5 g). The Composix group had a higher number of minor complications (Clavien I, II) and secondary procedures. Conclusions: This single-surgeon cohort with five-year followup demonstrated a large improvement and maintenance of continence in all three surgical groups. The Composix-based sling provided comparable continence outcomes at a fraction of the cost; however, its increased morbidity and higher complication rate raise concerns over future use

Intraoperative and early postoperative complications in women with stress urinary incontinence treated with suburethral slings: a randomised trial.

“…Urinal bladder perforation is one of the most common intraoperative complications. Studies have demonstrated this in 0.7-24% of TVT procedures [17,[21][22][23]. Our result is consistent with the one reported by Ford et al [9] (4.5%), who analysed 8,652 TVT procedures.…”

“…This can be explained by the lower percentage of urinal bladder perforations and fewer voiding difficulties after surgery in this group of patients. In the studies of Ben Zav et al [21] and Luo et al [22], damage to the urinal bladder was only observed during the TVT procedure. In our material, post-operative urine retention occurred twice as many times as among patients who underwent TVT, whereas Ben Zvi et al [21] and Cavkaytar et al [11] observed this kind of complication in an equal percentage among patients operated on using the TOT and TVT procedure.…”

“…In our study, early post-operative complications occurred in 20% of the patients in the TVT group but only in 8.0% of the patients in the TOT group. Other studies have revealed early post-operative complications after a TVT procedure in 2.9 to 19.5% [11,17,21,27,30]. Bianchi-Ferraro et al [31] noted early post-operative urinal retention, urinary tract infections, groin pain, and urgency de novo in 3.5%, 7.1%, 26.7%, and 3.5% of patients, respectively.…”

“…In the TVT group, post-operative problems with micturition were observed in 14.0%: 3.0% of the patients suffered from dysuria, 10.0% reported voiding difficulties, and urgency de novo was noted in 1.0%. The range in which urinary retention is reported is wide, from 2.2% to 4.4% [11,21,27], as is that for post-operative problems with micturition, from 1.0% to 28.0% [32,33]. In transobturator tape placement, the risk of urinary retention is lower than in the case of the TVT procedure, and varies from 1.0% to 11.0% [17,34,35].…”