A randomised controlled equivalence trial comparing tension-free vaginal tape (TVT) with suprapubic urethral support sling (SPARC)

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[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
Original languageEnglish
StateUnpublished - 2007

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