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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
Author(s) -
LORD H. ELIZABETH,
TAYLOR JOHN D.,
FINN JUDITH C.,
TSOKOS NICOLAS,
JEFFERY J. TIMOTHY,
ATHERTON MICHELLE J.,
EVANS SHARON F.,
BREMNER ALEXANDRA P.,
ELDER GILLIAN O.,
HOLMAN C. D’ARCY J.
Publication year - 2006
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2006.06333.x
Subject(s) - medicine , urinary incontinence , urology , confidence interval , surgery , blood loss , odds ratio , randomized controlled trial , perforation , sling (weapon) , materials science , punching , metallurgy
OBJECTIVE To 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 METHODS Patients 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. RESULTS There 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, 21.8%; SPARC 28/154, 18.2%); de novo urgency (TVT 15/37, 40.5%; SPARC 14/33, 42.4%), objective cure (TVT 143/147, 97.3%; SPARC 148/152, 97.4%) or vaginal mesh erosion (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. CONCLUSION These 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.