BACKGROUND: Evidence comparing the effectiveness of tension-free vaginal tape (TVT) with Burch colposuspension (CS) over a long-term follow-up is scarce. PURPOSE: To compare TVT with CS as primary treatment for female stress urinary incontinence (SUI). DESIGN: Open randomised clinical trial with a three-year follow-up period. PARTICIPANTS: 49 consecutive women aged 35 to 70 with SUI demonstrated by a urodynamic study. SETTING:Urology department of Severo Ochoa general hospital in Leganes, Madrid, Spain. INTERVENTION: 24 random patients treated withTVT and 25 with CS. MEASUREMENTS: Main variable: assessment before treatment and at six months, one year and three years after the operation using the incontinence severity index (ISI) and the incontinence impact questionnaire (IIQ). Secondary variable: three groups for assessing cure, improvement and failure rates. RESULTS: Time in surgery, consumption of postoperative analgesics and length of the postoperative hospital stay were lower in the TVT group (41.1 +/- 10.9 minutes; 6 [2.8-10.5] capsules and 1 [1-2] days vs. 57.1 +/- 18.3 minutes, 23.5 [18.0-31.5] capsules and 3 [3-3] days [p < 0.0001]). There was a significant reduction in ISI and IIQ scores in both groups and no differences in surgical complications, urgency, obstruction, one-hour pad test, urine culture, flowmetry, costs and cure rates at any moment during follow-up (cured/improved 76.2%, 78.3% and 77.3% at six months, one year and three years for TVT vs. 87.5%, 87.5% and 91.3% for CS; p = 0.32, p = 0.4 and p = 0.19). LIMITATIONS: The trial is open, which can create observer bias. A study with a higher number of patients or a longer follow-up time could show differences between the procedures that we were unable to observe in this study, due to our budget and time limits. DISCUSSION: Based on both short-term and long-term results, TVT is as effective as CS for the treatment of SUI, and has similar subjective cure and surgical complication rates. Time in surgery, consumption of analgesics and length of postoperative hospital stay are all lower in the TVT group. In our clinical setting, with a one-day postoperative stay for TVT, the two procedures have similar costs.
RCT Entities:
BACKGROUND: Evidence comparing the effectiveness of tension-free vaginal tape (TVT) with Burch colposuspension (CS) over a long-term follow-up is scarce. PURPOSE: To compare TVT with CS as primary treatment for female stress urinary incontinence (SUI). DESIGN: Open randomised clinical trial with a three-year follow-up period. PARTICIPANTS: 49 consecutive women aged 35 to 70 with SUI demonstrated by a urodynamic study. SETTING: Urology department of Severo Ochoa general hospital in Leganes, Madrid, Spain. INTERVENTION: 24 random patients treated with TVT and 25 with CS. MEASUREMENTS: Main variable: assessment before treatment and at six months, one year and three years after the operation using the incontinence severity index (ISI) and the incontinence impact questionnaire (IIQ). Secondary variable: three groups for assessing cure, improvement and failure rates. RESULTS: Time in surgery, consumption of postoperative analgesics and length of the postoperative hospital stay were lower in the TVT group (41.1 +/- 10.9 minutes; 6 [2.8-10.5] capsules and 1 [1-2] days vs. 57.1 +/- 18.3 minutes, 23.5 [18.0-31.5] capsules and 3 [3-3] days [p < 0.0001]). There was a significant reduction in ISI and IIQ scores in both groups and no differences in surgical complications, urgency, obstruction, one-hour pad test, urine culture, flowmetry, costs and cure rates at any moment during follow-up (cured/improved 76.2%, 78.3% and 77.3% at six months, one year and three years for TVT vs. 87.5%, 87.5% and 91.3% for CS; p = 0.32, p = 0.4 and p = 0.19). LIMITATIONS: The trial is open, which can create observer bias. A study with a higher number of patients or a longer follow-up time could show differences between the procedures that we were unable to observe in this study, due to our budget and time limits. DISCUSSION: Based on both short-term and long-term results, TVT is as effective as CS for the treatment of SUI, and has similar subjective cure and surgical complication rates. Time in surgery, consumption of analgesics and length of postoperative hospital stay are all lower in the TVT group. In our clinical setting, with a one-day postoperative stay for TVT, the two procedures have similar costs.