A randomized controlled equivalence trial of short‐term complications and efficacy of tension‐free vaginal tape and suprapubic urethral support sling for treating stress incontinence

Abstract

RESULTSThere were 301 operations; the difference in bladder perforations was not statistically significant, at one/147 TVT (0.7%), and three/ 154 SPARC (1.9%), with the difference in rate of 0.013 (95% confidence interval (CI) − 0.01 to 0.04; odds ratio 2.89, 95% CI 0.30-28.21; P = 0.62), and nor were differences in estimated blood loss of > 100 mL (TVT, 32/147,21 (TVT 7/147, 4.8%; SPARC 16/152, 10.5%). Acute urinary retention (TVT none of 147; SPARC 10/154, 6.5%; odds ratio ∞ , 95% CI 2.2-∞ ; P = 0.002) and subjective cure (TVT 128/147, 87.1%; SPARC 117/153, 76.5%; odds ratio 2.07, 95% CI 1.13-3.81; P = 0.03) were statistically significantly different. CONCLUSIONThese results are consistent with clinical equivalence between TVT and SPARC for bladder perforation. There was no statistically significant difference between TVT and SPARC in blood loss, urgency or objective cure of SUI symptoms at 6 weeks. However, SPARC was more difficult to adjust correctly, and a statistically significant number of patients required loosening of the tape in theatre ( P = 0.002). TVT had a lower rate of vaginal erosion and a statistically significantly higher cure rate of subjective SUI symptoms than SPARC. Overall, voiding difficulty (loosening of the tape), urgency and vaginal mesh erosion were the most important clinical problems. This trial showed the importance of testing new devices which appear to be similar, but which might have relevant differences. There was no financial assistance for this study, and a long-term follow up is planned. KEYWORDSrandomized controlled trial, TVT, SPARC, stress incontinence, complications, erosion OBJECTIVETo establish the equivalence between the tension-free vaginal tape (TVT) and the suprapubic urethral support sling (SPARC). Approximately 35% of women have stress urinary incontinence (SUI), and although TVT is now perceived as the standard treatment, the SPARC is a very similar procedure and is thought to have fewer peri-operative complications. PATIENTS AND METHODSPatients with clinical SUI were recruited from public and private urology/urogynaecology clinics, and participated in the trial of TVT vs SPARC. The primary outcome was bladder perforation; secondary outcomes were blood loss, voiding difficulty, urgency, and cure of SUI symptoms. Sample size calculations, based on an estimated 2% perforation rate, showed that 290 patients would be needed to detect a clinically significant difference of 5%. Stratification was by previous incontinence surgery and the experience of the surgeon.

Lynx® midurethral sling system: a 1-year prospective study on efficacy and safety

“…However, two of the five did develop recurrent stress incontinence at their 1-year follow-up appointment and are currently using alternate forms of therapy. Erosion rates reported in the literature range from 0.7% to 10.5% with similar type of polypropylene mesh [11,13,14,16]. In our experience, the modifications made to the Advantage mesh did not seem to reduce erosion rates.…”

“…There has been some controversy as to the comparable success rates when comparing the top-down vs. the bottom-up approach. There have been four randomized, prospective studies comparing the TVT sling (bottom-up) to the suprapubic arch (SPARC) sling (top-down) [9][10][11][12]. Three of the four studies showed equivalence of the TVT to the SPARC sling systems [9,10,12] with the longest follow-up at 25 months showing continence rates of 87% vs. 81%, respectively.…”

“…[12] However, a study by Lord et al, which had the largest number of patients (147 TVT vs. 154 SPARC), showed superiority of the TVT over the SPARC with 87% vs. 77% success rates, respectively. [11] Our study, which is a topdown approach, demonstrated a 90% subjective and objective resolution of stress incontinence based on those available for follow-up at 1 year. If reported as an intent-totreat analysis, our success rate would fall to 78%.…”

The Effectiveness and Complications of Double-Forced Sling Method in Stress Incontinence Surgery

“…In another study, with the use of synthetic materials, this rate ranged between 0% and 12% [21]. In the only randomized controlled equivalence trial comparing extrusions rates between TVT and SPARC, Lord et al [22] reported rates of 4.8% and 10.5% respectively. In our study, however, vaginal extrusion rate was 2.77%.…”

Modified pubovaginal sling technique in the surgical management of female stress urinary incontinence

“…The rate of bladder / urethral injury reported, according to several authors, ranges from zero to 13.8% [19][20][21][24][25][26][27] . In our series, we had no adverse outcomes in this regard.…”