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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.
BJU Int. 2006 Aug; 98(2):367-76.BI

Abstract

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 infinity, 95% CI 2.2-infinity; 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.

Links

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Authors+Show Affiliations

Lord HE
Faculty of Medicine and Dentistry, School of Population Health, University of Western Australia, Western Australia, Australia. elord@cyllene.uwa.edu.au
Taylor JD
No affiliation info available
Finn JC
No affiliation info available
Tsokos N
No affiliation info available
Jeffery JT
No affiliation info available
Atherton MJ
No affiliation info available
Evans SF
No affiliation info available
Bremner AP
No affiliation info available
Elder GO
No affiliation info available
Holman CD
No affiliation info available

MeSH

AdultAgedAged, 80 and overFemaleHumansMiddle AgedSurgical MeshTreatment OutcomeUrethraUrinary Incontinence, StressUrodynamicsVagina

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16879679

Citation

Lord, H Elizabeth, et al. "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." BJU International, vol. 98, no. 2, 2006, pp. 367-76.
Lord HE, Taylor JD, Finn JC, et al. 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. BJU Int. 2006;98(2):367-76.
Lord, H. E., Taylor, J. D., Finn, J. C., Tsokos, N., Jeffery, J. T., Atherton, M. J., Evans, S. F., Bremner, A. P., Elder, G. O., & Holman, C. D. (2006). 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. BJU International, 98(2), 367-76.
Lord HE, et al. 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. BJU Int. 2006;98(2):367-76. PubMed PMID: 16879679.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Lord,H Elizabeth, AU - Taylor,John D, AU - Finn,Judith C, AU - Tsokos,Nicolas, AU - Jeffery,J Timothy, AU - Atherton,Michelle J, AU - Evans,Sharon F, AU - Bremner,Alexandra P, AU - Elder,Gillian O, AU - Holman,C D'Arcy J, PY - 2006/8/2/pubmed PY - 2006/8/24/medline PY - 2006/8/2/entrez SP - 367 EP - 76 JF - BJU international JO - BJU Int VL - 98 IS - 2 N2 - 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 infinity, 95% CI 2.2-infinity; 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. SN - 1464-4096 UR - https://www.unboundmedicine.com/medline/citation/16879679/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_ L2 - https://doi.org/10.1111/j.1464-410X.2006.06333.x DB - PRIME DP - Unbound Medicine ER -