Objective: A randomized prospective comparison of two synthetic mid-urethral tension-free slings was undertaken at a university hospital to evaluate clinical efficacy, complication rates, and ease of procedure and training residents.
Methods: Between January 2004 and September 2005, 96 women with stress urinary incontinence were consecutively assigned to Gynecare TVT® or Boston Scientific Lynx® mid-urethral slings (n=48 in each group) at the University of Nebraska Medical Center. Both groups were similar in mean age, parity, weight, preoperative post-void residual, cystometric capacity, flow rate, and urethral closure pressures. Postmenopausal status and previous incontinence surgery rates were also comparable. Intraoperative complications, ease of trocar placement, postoperative voiding difficulties, subjective and objective cure rates, and postoperative interventions were assessed. During statistical analysis, p<0.05 was used as cut-off for significance.
Results: Half of the patients in both groups underwent multiple procedures. There were two (4%) trocar injuries with the TVT and three (6%) with the Lynx (p=.21). Early postoperative voiding dysfunction was 21% (10 patients) for the TVT group versus 15% (7 patients) for the Lynx (p<0.001), whereas prolonged catheterization for two weeks was similar at 4% (2 patients) for both. UTI rate for the TVT was 10% (5 patients) and 13% (6 patients) for Lynx (p=0.02). Subjective cure rates were 94% (45 patients) and 92% (44 patients), respectively (p=.08). Urethral closure pressure <14 cm H2O was the identifiable risk for objective failure. Objective cure rates were 96% (46 patients) for the TVT and 94% (45 patients) for the Lynx (p=.12), suggesting that some subjective failure was likely due to de novo bladder overactivity. One sling in the Lynx group was removed for skin cellulites, and one sling slit in TVT group was removed for voiding dysfunction due to duplicated ureter on the left side.
Conclusion: Despite similar efficacy, complication rates, and failure rates, the incidence of postoperative voiding difficulties was better with Lynx, due likely to the mid-urethral seal. However, it was difficult to place the Lynx trocar in patients with prior surgeries, probably due to the blunt needle and notch. An increased rate of vaginal graft exposure was seen with the Lynx. Residents favored the Lynx trocar because of its light weight and greater stability.
Keywords: TVT, Lynx, Synthetic mid-urethral tension-free slings
Correspondence: Neena Agarwala, University of Nebraska Medical Center, Omaha, NE 68198, firstname.lastname@example.org
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