[Truncated abstract] Approximately 35% of women worldwide have stress incontinence, which is defined as involuntary leakage of urine on effort, exertion, or on sneezing and coughing. There are various surgical techniques for stress incontinence; however, minimally invasive operations are increasingly being chosen by surgeons and their patients. Of these procedures, tension-free vaginal tape (TVT) has a cure rate of approximately 90% and is now perceived as the standard technique for stress incontinence. Reported complications of TVT include arterial laceration, bladder perforation, bowel perforation, de novo urgency, dyspareunia, excessive blood loss, haematoma, nerve injuries, urethral erosion, urge incontinence, urinary tract infection, vascular injury, vaginal mesh erosion, voiding dysfunction and death. Suprapubic urethral support sling (SPARC) is a very similar minimally invasive operation and early indications suggested that the success rate for treating stress incontinence was expected to be identical or better than those obtained with the earlier TVT approach, with possibly fewer adverse perioperative events. Our trial sought to establish equivalence between TVT and SPARC in relation to short-term complications and efficacy. OBJECTIVES The primary outcome was bladder perforation. Secondary outcomes were blood loss, voiding difficulty, urgency, and cure of stress incontinence symptoms. METHOD A randomised controlled one-sided equivalence trial (RCT) was conducted in Perth, Western Australia during 2003 and 2004 by researchers in the School of Population Health, University of Western Australia (UWA) and King Edward Memorial Hospital (KEMH). Patients were recruited from the public Urology/Urogynaecology Clinic at the primary women's hospital and the consultant surgeons' private practices. ... However, acute urinary retention requiring a return to theatre to loosen the tape (TVT 0%, SPARC 6.5%; OR: [infinity], 95% CL: 2.2, [infinity]; p=0.002) and subjective short-term cure (TVT 87.1%, SPARC 76.5%; OR: 2.07, 95% CL: 1.13, 3.81; p=0.03) were statistically significantly different. CONCLUSIONS The results are consistent with clinical equivalence between TVT and SPARC in relation to the incidence of bladder perforation. No statistically significant difference was found between TVT and SPARC in blood loss, urgency or short-term objective cure of stress incontinence at the six week post-discharge visit to the surgeon. However, the tapes were more difficult to adjust correctly in SPARC procedures and a statistically significant number of patients required a return to theatre for loosening of the tape (TVT 0/147, 0% and SPARC 10/154, 6.5%, p=0.002). Compared with SPARC, TVT was statistically significantly higher for subjective short-term cure. In ii relation to vaginal mesh erosion, TVT was lower than SPARC, though not statistically significantly. Overall, voiding difficulty (loosening of the tape), urgency and vaginal mesh erosion were the most important clinical problems. This randomised controlled trial demonstrates the importance of testing new devices which appear to be similar, but which may have clinically relevant differences. A follow up study to assess the long-term efficacy of tension-free vaginal tape and suprapubic urethral support sling and associated complications is planned.
| Identifer | oai:union.ndltd.org:ADTP/216894 |
| Date | January 2008 |
| Creators | Lord, Helen Elizabeth |
| Publisher | University of Western Australia. Faculty of Medicine and Dentistry and Health Sciences |
| Source Sets | Australiasian Digital Theses Program |
| Language | English |
| Detected Language | English |
| Rights | Copyright Helen Elizabeth Lord, http://www.itpo.uwa.edu.au/UWA-Computer-And-Software-Use-Regulations.html |
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