PURPOSE: We characterized continence, satisfaction and adverse events in women at least 5 years after Burch urethropexy or fascial sling with longitudinal followup of randomized clinical trial participants. MATERIALS AND METHODS: Of 655 women who participated in a randomized surgical trial comparing the efficacy of the Burch and sling treatments 482 (73.6%) enrolled in this long-term observational study. Urinary continence status was assessed yearly for a minimum of 5 years postoperatively. Continence was defined as no urinary leakage on a 3-day voiding diary, and no self-reported stress incontinence symptoms and no stress incontinence surgical re-treatment. RESULTS: Incontinent participants were more likely to enroll in the followup study than continent patients (85.5% vs 52.2%) regardless of surgical group (p<0.0001). Overall the continence rates were lower in the Burch urethropexy group than in the fascial sling group (p=0.002). The continence rates at 5 years were 24.1% (95% CI 18.5 to 29.7) vs 30.8% (95% CI 24.7 to 36.9), respectively. Satisfaction at 5 years was related to continence status and was higher in women undergoing sling surgery (83% vs 73%, p=0.04). Satisfaction decreased with time (p=0.001) and remained higher in the sling group (p=0.03). The 2 groups had similar adverse event rates (Burch 10% vs sling 9%) and similar numbers of participants with adverse events (Burch 23 vs sling 22). CONCLUSIONS:Continence rates in both groups decreased substantially during 5 years, yet most women reported satisfaction with their continence status. Satisfaction was higher in continent women and in those who underwent fascial sling surgery, despite the voiding dysfunction associated with this procedure. Copyright Â
RCT Entities:
PURPOSE: We characterized continence, satisfaction and adverse events in women at least 5 years after Burch urethropexy or fascial sling with longitudinal followup of randomized clinical trial participants. MATERIALS AND METHODS: Of 655 women who participated in a randomized surgical trial comparing the efficacy of the Burch and sling treatments 482 (73.6%) enrolled in this long-term observational study. Urinary continence status was assessed yearly for a minimum of 5 years postoperatively. Continence was defined as no urinary leakage on a 3-day voiding diary, and no self-reported stress incontinence symptoms and no stress incontinence surgical re-treatment. RESULTS: Incontinent participants were more likely to enroll in the followup study than continent patients (85.5% vs 52.2%) regardless of surgical group (p<0.0001). Overall the continence rates were lower in the Burch urethropexy group than in the fascial sling group (p=0.002). The continence rates at 5 years were 24.1% (95% CI 18.5 to 29.7) vs 30.8% (95% CI 24.7 to 36.9), respectively. Satisfaction at 5 years was related to continence status and was higher in women undergoing sling surgery (83% vs 73%, p=0.04). Satisfaction decreased with time (p=0.001) and remained higher in the sling group (p=0.03). The 2 groups had similar adverse event rates (Burch 10% vs sling 9%) and similar numbers of participants with adverse events (Burch 23 vs sling 22). CONCLUSIONS: Continence rates in both groups decreased substantially during 5 years, yet most women reported satisfaction with their continence status. Satisfaction was higher in continent women and in those who underwent fascial sling surgery, despite the voiding dysfunction associated with this procedure. Copyright Â
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