PURPOSE: To evaluate long-term (over 4 years) functional outcomes and quality of life of transobturator (TOR) and retropubic (RPR) routes in the cure of stress urinary incontinence (SUI). METHODS: Prospective, randomized multicentre study involving 88 women with SUI from March 2004 to May 2005 (RPR group (n = 42), TOR group (n = 46)). Long-term functional results and quality of life were evaluated using validated questionnaires and compared with those observed at the first year. RESULTS: Eight patients (19%) in the RPR group and 9 patients (19.5%) in the TOR group were lost to follow-up (NS). The mean follow-up in the RPR and the TOR groups was 52.7 months and 53.1 months, respectively. In intention to treat, the success rate at 4 years was 64.3% in the RPR group and 69.5% in the TOR group (NS). At 4 years, no significant differences in the IIQ scores were observed in either group compared to the preoperative scores with no difference between the groups (RPR group: 32 vs. 14.9 (NS), TOR group: 25.7 vs. 21.4 (NS)). Compared to 1 year UDIQ and IIQ scores, a decrease in quality of life was observed for both groups at 4 years (RPR group: 4.7 vs. 34 (P < 0.0001) and 2.6 vs. 14.9 (P < 0.001), TOR group: 1.2 vs. 38.7 (P < 0.0001) and 0 vs. 21.4 (P < 0.0001)) without difference between the groups. CONCLUSIONS: This study shows similar relatively high long-term success rates for both the RPR and TOR procedures. Patients should be informed about a possible time-dependent alteration in functional results.
RCT Entities:
PURPOSE: To evaluate long-term (over 4 years) functional outcomes and quality of life of transobturator (TOR) and retropubic (RPR) routes in the cure of stress urinary incontinence (SUI). METHODS: Prospective, randomized multicentre study involving 88 women with SUI from March 2004 to May 2005 (RPR group (n = 42), TOR group (n = 46)). Long-term functional results and quality of life were evaluated using validated questionnaires and compared with those observed at the first year. RESULTS: Eight patients (19%) in the RPR group and 9 patients (19.5%) in the TOR group were lost to follow-up (NS). The mean follow-up in the RPR and the TOR groups was 52.7 months and 53.1 months, respectively. In intention to treat, the success rate at 4 years was 64.3% in the RPR group and 69.5% in the TOR group (NS). At 4 years, no significant differences in the IIQ scores were observed in either group compared to the preoperative scores with no difference between the groups (RPR group: 32 vs. 14.9 (NS), TOR group: 25.7 vs. 21.4 (NS)). Compared to 1 year UDIQ and IIQ scores, a decrease in quality of life was observed for both groups at 4 years (RPR group: 4.7 vs. 34 (P < 0.0001) and 2.6 vs. 14.9 (P < 0.001), TOR group: 1.2 vs. 38.7 (P < 0.0001) and 0 vs. 21.4 (P < 0.0001)) without difference between the groups. CONCLUSIONS: This study shows similar relatively high long-term success rates for both the RPR and TOR procedures. Patients should be informed about a possible time-dependent alteration in functional results.
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